Trilogy AB Acetabular System

• • Terminated Z-1684-2016 FDA Class II ·initiated 4 May 2016

  A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.

• 4 recalls, same reason

  • Terminated Z-1161-2016 FDA Class II ·initiated 11 Jan 2016
  • Terminated Z-1115-2016 FDA Class II ·initiated 11 Jan 2016
  • Terminated Z-1145-2016 FDA Class II ·initiated 11 Jan 2016
  • Terminated Z-1123-2016 FDA Class II ·initiated 11 Jan 2016

  As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

• • Terminated Z-0875-2015 FDA Class II ·initiated 4 Dec 2014

  Zimmer received a single complaint wherein a Trilogy® Fiber Metal Multi-Hole Acetabular Shell would not attach to the inserter/impactor instrumentation. Subsequent investigation found the polar-hole threads to be present but non-conforming to specifications, in that the minor diameter was undersized. Investigation also indicates that the issue is isolated and affects only lot 62714305, which

• • Terminated Z-0824-2015 FDA Class II ·initiated 21 Nov 2014

  Analysis of returned complaint devices, product in inventory, and device manufacturing records has identified tool marks isolated to one specific machining mill to be the cause of the fractures. .

• • Terminated Z-2032-2014 FDA Class II ·initiated 12 Jun 2014 ·on shared 510(k) K934765

  Two lots of screws were commingled. Screws with etching and machining for lot number 62629432 were packaged in bags labeled for lot number 62628759; and screws with etching and machining for lot number 62628759 were packaged in bags labeled for lot number 62629432. The affected product was distributed between 3/6/14 and 4/21/14.

• 2 recalls, same reason

  • Terminated Z-1028-2014 FDA Class II ·initiated 11 Oct 2013 ·on shared PMA P040048
  • Terminated Z-1024-2014 FDA Class II ·initiated 11 Oct 2013

  Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.

• 7 recalls, same reason

  • Terminated Z-0774-2013 FDA Class II ·initiated 14 Sep 2012 ·on shared PMA P040048
  • Terminated Z-0772-2013 FDA Class II ·initiated 14 Sep 2012
  • Terminated Z-0776-2013 FDA Class II ·initiated 14 Sep 2012 ·on shared PMA P040048
  • Terminated Z-0771-2013 FDA Class II ·initiated 14 Sep 2012
  • Terminated Z-0769-2013 FDA Class II ·initiated 14 Sep 2012
  • Terminated Z-0773-2013 FDA Class II ·initiated 14 Sep 2012
  • Terminated Z-0775-2013 FDA Class II ·initiated 14 Sep 2012

  Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the pore size specification (as low as 28% vs. 30% porosity specification). On 10/31/2012, the firm expanded the recall action to include lots of Uni-Hole Trilogy Acetabular System shells.

• • Terminated Z-1616-2009 FDA Unclassified (pre-2012) ·initiated 29 May 2009 ·on shared PMA P040048

  The corner tab of the inner compartment lid was not folded under before the outer lid was sealed, resulting in lack of assurance of sterility.

• • Terminated Z-0620-2008 FDA Unclassified (pre-2012) ·initiated 19 Oct 2007

  Parts missing and incomplete etch: The units may not contain the locking ring or the etched alignment marks on the rim.

• • Terminated Z-1344-06 FDA Unclassified (pre-2012) ·initiated 26 Jun 2006 ·on shared 510(k) K934765

  Lack of assurance of sterility, as the sterile barrier packaging may have been compromised.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Generic name

Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented

PMA number

P040048 ↗

510(k) Number

K934765 ↗

FDA product code

LPH

Device class

Class II

Regulation

21 CFR Part 888.3358

Advisory committee

Orthopedic

FDA decision

SESE Substantially Equivalent

• OsseoFit 00-5381-008-05

  Class I

  GUDID on market

• OsseoFit 00-5381-013-00

  Class I

  GUDID on market

• OsseoFit 00-5381-008-06

  Class I

  GUDID on market

• OsseoFit 00-5381-013-11

  Class I

  GUDID on market

• OsseoFit 00-5381-013-10

  Class I

  GUDID on market

• OsseoFit 00-5381-013-13

  Class I

  GUDID on market

See all devices from Zimmer, Inc. →

• What is the Trilogy AB Acetabular System used for?

  The system is a semi-constrained hip prosthesis intended for the rehabilitation of hips damaged by noninflammatory degenerative joint disease, such as osteoarthritis, avascular necrosis, congenital hip dysplasia, and traumatic arthritis.

• Can the Trilogy AB Acetabular System be used with cement?

  Yes, the device is indicated for either cemented or noncemented use, allowing surgeons to select the fixation method appropriate for the patient's clinical needs.

• Who is the intended patient for this hip prosthesis?

  The device is indicated for use in skeletally mature individuals who are undergoing primary surgery to address hip joint damage.