MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 UNK HIP FEMORAL HEAD METAL ASR; METAL FEMORAL HEAD

Catalog Number UNK HIP HEAD METAL ASR

Device Problem Noise, Audible (3273)

Patient Problems Fatigue (1849); Pain (1994); Ambulation Difficulties (2544); Physical Asymmetry (4573); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/05/2020

Event Type  Injury  

Manufacturer Narrative

(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

Asr revision.Medical records received.After review of medical record patient was revised to addressed pain and elevated metal ions levels.Patient experiencing limping, popping, weakness and left is shorter than his right hip.There was some mascroscopic deposition at the base of the trunnion however there was no mascroscopic damage in the trunnion.Doi: (b)(6) 2009.Dor: (b)(6) 2020; left hip.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary this hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.Further investigation of this individual incident will not be undertaken.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Device history lot previous investigations that have included device history reviews since the asr platform was launched have shown no indication of deviations or anomalies with regard to material, manufacturing, or inspection.Therefore, no device history record (dhr) review for this individual asr component will be carried out at this point in time.

• Brand Name: UNK HIP FEMORAL HEAD METAL ASR
• Type of Device: METAL FEMORAL HEAD
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 12197085
• MDR Text Key: 262468533
• Report Number: 1818910-2021-15535
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 06/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP HEAD METAL ASR
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Treatment: +5 TAPER SLEEVE ADAPTER; OFFSET TAPERED STEM WITH DOUFIX S9; S53; S60; +5 TAPER SLEEVE ADAPTER; OFFSET TAPERED STEM WITH DOUFIX S9; S53; S60
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR