MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ASR ACETABULAR CUPS 52; ASR HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number 999800752

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

Patient Problems Adhesion(s) (1695); Hypersensitivity/Allergic reaction (1907); Pain (1994); Distress (2329); Osteolysis (2377)

Event Date 06/19/2019

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

Litigation and medical records received.Litigation records alleges emotional distress, economic loss as well as punitive damages.After review of medical records patient was revised to addressed failed right total hip arthroplasty due to pain.Mri showed significant pseudotumor and increased metal ion level with cobalt of 64 and chromium of 43.Pseudotumor that was involving her hip abductors coupled with a subsided stem that appeared to be somewhat chronic in nature with marked osteolysis of the femur.The hip was dislocated after clearing all redundant scar tissue.The stem was able to be removed with shoe clip.There was a significant pedestal present.Doi: (b)(6) 2009.Dor: (b)(6) 2019.Right hip.

Manufacturer 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.Device history lot : the asr platform was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive.An mre (device history record) review will not be performed even when lot code(s) are known.

• Brand Name: ASR ACETABULAR CUPS 52
• Type of Device: ASR HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 12365722
• MDR Text Key: 268072081
• Report Number: 1818910-2021-18620
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: K040627
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 08/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/20/2013
• Device Catalogue Number: 999800752
• Device Lot Number: 2730708
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ASR ACETABULAR CUPS 52; ASR TAP SLV ADAP 12/14 -1; ASR UNI FEMORAL IMPL SIZE 46; CORAIL2 STD SIZE 10; ASR ACETABULAR CUPS 52; ASR TAP SLV ADAP 12/14 -1; ASR UNI FEMORAL IMPL SIZE 46; CORAIL2 STD SIZE 10
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR