MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 9/10 ULTAMET 36MM HEADS +0; SMALL TAPER (9/10) FEMORAL HEADS : HIP METAL FEMORAL HEADS

Catalog Number 962711000

Device Problems Corroded (1131); Degraded (1153)

Patient Problems Necrosis (1971); Pain (1994); Osteolysis (2377); No Code Available (3191)

Event Date 01/01/2020

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

The primary surgery was performed on (b)(6) 2007 via tha.It was reported that the revision surgery was scheduled on (b)(6) 2020 by replacing the head (p/n; unknown) and the liner (p/n: unknown) due to the suspicion of armd which was caused by mom.

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.Corrected: h6 (device code).Product complaint # (b)(4).Investigation summary : no device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 9/10 ULTAMET 36MM HEADS +0
• Type of Device: SMALL TAPER (9/10) FEMORAL HEADS : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 10010536
• MDR Text Key: 189569622
• Report Number: 1818910-2020-11488
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 962711000
• Device Lot Number: 2343345
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 9/10 ULTAMET 36MM HEADS +0; AML A PLUS 10.0 MM; PINNACLE MTL INS NEUT36IDX52OD
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR