MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK HIP FEMORAL HEAD METAL; METAL FEMORAL HEAD

Catalog Number UNK HIP FEMORAL HEAD METAL

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Hematoma (1884); Joint Dislocation (2374); Joint Laxity (4526)

Event Date 01/01/2023

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).The device catalog number is unknown; therefore, udi is unavailable.Initial reporter occupation: lawyer.Component code: appropriate term/code not available (g07002) used to capture no findings available.Investigation summary: no device associated with this report was received for examination.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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.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.

Event Description

On (b)(6) 2021, the patient had a right hip bearing surface revision due to failed right total hip arthroplasty secondary to metallosis.It was noted that the femoral head that was removed was a femoral head for the srom femoral stem.There was mild burnishing of the trunnion.The burnishing on the trunnion was removed along with debris from the trunnion.The stem was retained.The surgeon observed a fair amount of fibrinous tissue debris consistent with a pseudotumor.The metal liner was revised and a poly liner was implanted.No mention of the manufacturer, but it may be assumed that if the components implanted were depuy since the revised liner was known to be metal depuy liner and the femoral head that was removed was metal srom ((b)(4)).On (b)(6) 2022 the patient had a right hip bearing surface revision to address recurrent dislocation.It was noted that the patient had 2 dislocations a month apart.The patient had developed instability.The surgeon observed a hematoma.The femoral components were noted to be in excellent position and well fixed.The acetabular cup was well fixed and retained.The poly liner and femoral head were removed and a dual mobility component was implanted.No part/lot information provided in these records.Doi (head and liner): (b)(6) 2021; dor: (b)(6) 2022; right hip.

• Brand Name: UNK HIP FEMORAL HEAD METAL
• Type of Device: METAL FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 16564423
• MDR Text Key: 311488280
• Report Number: 1818910-2023-06099
• Device Sequence Number: 1
• Product Code: JDI
• 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
• Type of Report: Initial
• Report Date: 03/17/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD METAL
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/01/2023
• Initial Date FDA Received: 03/17/2023
• 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 Sequence Number: 1
• Treatment: UNK HIP ACETABULAR LINER POLY.; UNK HIP FEMORAL HEAD METAL.
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male