MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ELITE MODULAR HD 32MM +0; SMALL TAPER (9/10) FEMORAL HEADS : HIP METAL FEMORAL HEADS

Catalog Number	962575000
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Unspecified Infection (1930); Joint Dislocation (2374); No Code Available (3191)
Date of Event	05/25/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Primary surgery date approx 30 years ago, 1st revision on (b)(6) 2019 (captured as (b)(4)) with subsequent revision and washout.Subsequent to the above, the patient has several dislocations.To remedy this issue, the patient underwent a second revision where the biomet liner was removed and exchanged for a captive liner.The depuy head was left in situ.Patient has the presented with an infected hip, and has undergone 1 washout.This was the second washout and the surgeon has elected to exchange the captive liner (biomet) along with the femoral head (b)(6) 2019.
Additional 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.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Corrective action was not indicated.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: ELITE MODULAR HD 32MM +0
• Common Device Name: SMALL TAPER (9/10) FEMORAL HEADS : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8 DT; UK LS11 8 DT
• MDR Report Key: 8700193
• Report Number: 1818910-2019-96008
• Device Sequence Number: 1680988
• Product Code: JDI
• UDI-Device Identifier: 10603295243182
• UDI-Public: 10603295243182
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K871867
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2019

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 962575000
• Device Lot Number: D17100288
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/25/2019
• Supplement Date Received by Manufacturer: 08/01/2019
• Initial Report FDA Received Date: 06/14/2019
• Supplement Report FDA Received Date: 08/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR