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

Catalog Number UNK HIP ACETABULAR LINER

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

Patient Problems Joint Dislocation (2374); Osteolysis (2377); No Code Available (3191)

Event Date 05/01/2006

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.(b)(4).

Event Description

The literature article entitled, "a randomized prospective evaluation of outcomes after total hip arthroplasty using cross-linked marathon and non¿cross-linked enduron polyethylene liner" written by c.Anderson engh jr, md, adam s.Stepniewski, md, stuart d.Ginn, bs, sarah e.Beykirch, bs, christi j.Sychterz-terefenko, ms, robert h.Hopper jr, phd, and charles a.Engh, md published by the journal of arthroplasty vol.21 no.6 suppl.2 2006 accepted by publisher 1 may 2006 was reviewed.The article's purpose to report on the results of a randomized prospective study to compare the clinical outcome of tha patients randomized to cross-linked marathon (depuy) liners with that of patients randomized to conventional non-cross-linked enduron (depuy) liners.Data was compiled from 236 hips (226 patients) receiving implants between january 1999 and july 2000.The article does not identify the femoral stem associated with the adverse events but separates the adverse events between the two platform of poly liners.Depuy products utilized: cementless femoral stem (aml, solution or prodigy), poly liners (enduron or marathon), cocr head , duraloc cup with apical hole plug.Adverse events associated with enduron: avulsion fracture of lesser trochanter associated progressive femoral osteolysis due to poly wear (treated by revision of liner), recurrent dislocations (treated by closed reduction and revision), adverse events associated with marathon: dislocation (treated by closed reduction and open reduction with liner exchange), periprosthetic femoral shaft fracture but no revision, loose stem accompanying progressive subsidence (no revision as patient was asymptomatic), osteolysis associated with liner wear (treated by revision of liner exchange).

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.The information received will be retained for potential series investigations if triggered by trend analysis or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.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: 9432035
• MDR Text Key: 185262887
• Report Number: 1818910-2019-121567
• 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: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 11/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2019
• 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: 01/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention