MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP ACETABULAR LINERS

Catalog Number UNK HIP ACETABULAR LINER

Device Problems Fracture (1260); Device Dislodged or Dislocated (2923); Naturally Worn (2988)

Patient Problem No Code Available (3191)

Event Date 01/01/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Literature article entitled, "119 retrieval analysis of dissociated polyethylene liner in pinnacle acetubular components" by ahmed el-bakoury, asif parkar, and james powell.University hospitals plymouth nhs trust, plymouth,uk.Queens hospital, london, uk.University of calgary, calgary, canada.Canadian arthroplasty association, westmount, canada.Background: one of the potential complications of polyethylene liner (pl) is its dissociation from the metal shell.This is a rare but catastrophic complication of the total hip replacement (thr).Objective: was to analyze the retrieved dissociated component (pl and shell) (depuy pinnacle, warsaw, in, usa) to evaluate the mechanism of failure.All these components were dissociated within four years of implantation.Methods: components were retrieved from three different centers in canada over the period from january 2011 to oct 2016.The analysis was done at the orthopaedic innovation center (oic) in winnipeg canada.Nine pls were retrieved at the time of revision thr.Assessment using optical and scanning electron microscopies at magnification between 25x and 150x was performed.The following questions were asked: 1) were the liners correctly seated at the primary surgery? 2 ) are there signs of impingement present which could have caused the liner to become dissociated? 3) does the wear pattern indicate that the liner was failing prior to dissociation? results: all pls dissociated in the inferior direction.Five pl were believed to have been seated properly at the time of indexed surgery.All pl displayed signs of post dissociation impingement.Only 1 pl had fractured resulting in failure prior to dissociation.Other pl showed signs of wear, however none of them reached thinness that would be a cause for concern.Eight pls demonstrated shearing of the anti rotation tabs.Assessment of the anti rotation tabs revealed that a couple had sheared off suddenly while remaining anti rotation tabls sheared off in progressive fatigue resulting in the failure of the locking mechanism.Conclusions: retrieval analysis was useful in identifying common patterns of failure such as anti-rotation tab damage.This was suggestive that the locking mechanism of acetebular components has probably failed in 8 out of 9 of the retrieved liners.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.This complaint was opened to document complaints derived through a journal article review.Follow-ups were done to try and obtain additional information from the author of the journal article.No further information was received.Device history lot null device history batch null device history review null if information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN HIP ACETABULAR LINERS
• Type of Device: HIP ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9842075
• MDR Text Key: 184463236
• Report Number: 1818910-2020-08221
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 03/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP ACETABULAR LINER
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention