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

Catalog Number UNK HIP CUP ASR

Device Problem Off-Label Use (1494)

Patient Problem Unspecified Infection (1930)

Event Date 01/01/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Occupation: lawyer.This device was also subject of (b)(4) as the patient experienced adverse events on different days with the same device.The device catalog number is unknown; therefore, udi is unavailable.(b)(4).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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.

Event Description

Infection was also manifested as patient was treated with iv antibiotic, antibiotic spacers and irrigation and debridement on the following dates ((b)(6) 2022) left hip.Sticker sheets attached were unreadable.Doi : (b)(6) 2009 ( cup & stem ), doi : (b)(6) 2022 (head & liners ), dor: (b)(6) 2022, left asr hip implant.

• Brand Name: UNK HIP ACETABULAR CUP ASR
• Type of Device: HIP ACETABULAR CUP
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer (Section G): DEPUY INT'L LTD. 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 15916639
• MDR Text Key: 304817577
• Report Number: 1818910-2022-24344
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 12/05/2022

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP CUP ASR
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/15/2022
• Initial Date FDA Received: 12/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Treatment: UNK HIP FEMORAL HEAD; UNK HIP FEMORAL STEM; UNKNOWN BI-MENTUM HIP ACETABULAR LINER; UNKNOWN HIP ACTEBULAR LINER
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male