MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL HEAD

Catalog Number UNK HIP FEMORAL HEAD

Device Problem Naturally Worn (2988)

Patient Problems Hypersensitivity/Allergic reaction (1907); Local Reaction (2035)

Event Date 11/10/2015

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

Unf and medical records received. After review of medical records patient was revised to address failed left total hip arthroplasty secondary to metal wear and hypersensitivity. Revision notes reported that there was metallic stained synovial fluid present and dissection was made down to the it band, which showed evidence of penetration by a large metallic pseudotumor. There was significant hypertrophic synovium, which was then excised. Ah of this was metallic stained. Doi: unknown. Dor: (b)(6) 2015; (left hip). The patient has bilateral hip implants, please see (b)(4) for the right hip.

• Brand Name: UNKNOWN HIP FEMORAL HEAD
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS 1818910; 700 orthopaedic dr; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 11024712
• MDR Text Key: 221999547
• Report Number: 1818910-2020-27123
• 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: CONSUMER,OTHER

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 12/07/2020

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 12/16/2020
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device Catalogue Number: UNK HIP FEMORAL HEAD
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/08/2021
• 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

Patient TREATMENT DATA

Date Received: 12/16/2020 Patient Sequence Number: 1

Treatment

UNKNOWN HIP ACETABULAR LINERS; UNKNOWN HIP FEMORAL HEAD