MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 UNKNOWN HIP ACETABULAR CUP

Catalog Number UNK HIP ACETABULAR CUP

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Anxiety (2328); Test Result (2695); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4). Initial reporter occupation: lawyer. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Claim letter received via email. Claim letter alleges that the patient has an enlargement in the groin area of unknown origin, elevated chromium and titanium levels, worry and concern. The claim letter has indicated that the claimant received both the asr xl and the asr resurfacing implants. This complaint record will capture the asr resurfacing implants. Doi: (b)(6) 2009. Dor: scheduled on (b)(6) 2020, (left hip).

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. H10 additional narrative: product complaint (b)(4). Investigation summary:no device associated with this report was received for examination. This hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive. 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 will be filed as appropriate.

• Brand Name: UNKNOWN HIP ACETABULAR CUP
• Type of Device: HIP ACETABULAR CUP
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 9681197
• Report Number: 1818910-2020-04223
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 01/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: UNK HIP ACETABULAR CUP
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Outcome(s): Required Intervention