MAUDE Adverse Event Report: ZIMMER INC STANDARD ACETABULAR LINER

Catalog Number 00672800800

Device Problems Failure To Adhere Or Bond (1031); Unstable (1667); Naturally Worn (2988)

Patient Problem Pain (1994)

Event Date 04/20/2010

Event Type  Injury  

Event Description

It is reported the patient was revised due to pain, instability, poly wear, acetabular loosening and polyethylene synovitis throughout the hip joint.This included a large lytic hole in the trochanteric area and another large lytic hole in the ischium.

Manufacturer Narrative

Evaluation summary: neither the devices themselves or photos of the revised devices have been returned for review, therefore their actual condition is unknown.With the acetabular liner being standard poly, and having an in-vivo time of over 13 years, it is probable that it experienced expected wear which led to some of the other symptoms described in the event.Other factors that may have accelerated this wear are unknown, such as the presence of bone cement in the joint, the fit and orientation of the devices, product compatibility of the femoral side components, etc.Neither operative notes nor x-rays have been provided.In general, patient factors that may affect the performance of the components include: age, bone quality, height/weight, activity level, type of activity and relevant medical history.Cause cannot be definitively determined.Review of the device history records was not possible as the lot numbers required for retrieval were unavailable.The investigation could not verify or identify any evidence of product contribution to the reported problem.

Manufacturer Narrative

Add'l info as well as the explanted liner has been returned for review.The liner is returned slightly yellowed, which can be expected after 13 years in vivo.Uneven articulation of the femoral head within the concave surface of the liner is evident by a spherical removal of material which is deviated from the intended center of rotation of the liner; 180 degrees from this deviated articulation, the convex surface of the liner shows an abrasion/wear pattern that indicated that it was tilted out of the acetabular shell for some time.The rim of the liner also shows damage and missing adjacent to the shifted femoral head articulation.Damage of the liner was too severe for proper dimensional analysis.The mfg documentation of the liner was reviewed and found conforming to spes at the time of manufacture.These devices were used in the treatment of a disease.A complaint history review of the mfg lot of the liner was performed with no add'l complaints identified.A definitive root cause cannot be stated.

Manufacturer Narrative

Evaluation summary: operative notes have been provided.Primary implantation notes of the devices was actually a revision procedure with severe wear of the poly and osteolysis present.It is now known that the zimmer components were implanted in conjunction with a depuy femoral stem and head.This is considered an off-label use of the device, which is indicated in the packaging insert, as zimmer has not tested the compatibility of this combination of devices.Revision operative notes state that the poly was disassociated from the shell and the locking ring was broken in the poly.Severe wear of the poly was described, and the shell was noted to be extremely solid.A definitive root cause cannot be stated, however it is possible that the patient's already existing osteolysis and previous poly wear may have contributed to the reported event.Review of the device history records was not possible as the lot numbers required for retrieval were unavailable.It is not suspected that the product failed to meet specifications.The investigation could not verify or identify any evidence of product contribution to the reported problem.Based on the available information, the need for corrective action is not indicated.Should additional substantive information be received, the complaint will be reopened.Zimmer, inc.Considers the investigation closed.

Manufacturer Narrative

This report is being amended to reflect changes.

• Brand Name: STANDARD ACETABULAR LINER
• Manufacturer (Section D): ZIMMER INC; p.o. box 708; warsaw IN 46581 0708
• Manufacturer Contact: kevin escapule ; 8006136131
• MDR Report Key: 3979818
• MDR Text Key: 4633595
• Report Number: 1822565-2014-00903
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 00672800800
• Device Lot Number: 63479600
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/17/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/25/2014
• Initial Date FDA Received: 07/24/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 09/03/2014; 07/21/2015; 08/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: LOT #UNK
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR