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U.S. Department of Health and Human Services

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

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DEPUY ORTHOPAEDICS INC US UNKNOWN HIP ACETABULAR LINERS Back to Search Results
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.
 
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Brand NameUNKNOWN HIP ACETABULAR LINERS
Type of DeviceHIP ACETABULAR LINERS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
JTE WARSAW MFG SITE
700 orthopaedic drive
warsaw IN 46582
Manufacturer Contact
kara ditty-bovard
700 orthopaedic drive
warsaw, IN 46581-0988
6107428552
MDR Report Key9842075
MDR Text Key184463236
Report Number1818910-2020-08221
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation Other Health Care Professional
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 Received03/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK HIP ACETABULAR LINER
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/15/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/17/2020 Patient Sequence Number: 1
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