MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ADAPTER SLEEVES 12/14 +2; ASR HIP SYSTEM : HIP FEMORAL SLEEVE

Catalog Number 999800312

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

Patient Problems Adhesion(s) (1695); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Necrosis (1971); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/11/2011

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).Initial reporter occupation: lawyer.Left hip revision reported in 1818910-2021-03502, 1818910-2021-03501, 1818910-2021-03499, 1818910-2021-03500; right hip revision reported in 1818910-2021-03503, 1818910-2021-03490, 1818910-2021-03489.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Asr supplemental info and medical records were received.After a review of the medical record, the patient was revised to address failed right total hip arthroplasty with likely metal on metal hypersensitivity reaction and cavitary lesion of the right ilium.Operative note reported of scarring of the abductor musculature, alval beneath the head and femoral component, scratches on the femoral head and cavitary defect extended into the ilium there was also some notable necrotic tissue in and around the hip capsule.Doi: (b)(6) 2007, dor: (b)(6) 2011, 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.A mre (device history record) review will not be performed.

• Brand Name: ADAPTER SLEEVES 12/14 +2
• Type of Device: ASR HIP SYSTEM : HIP FEMORAL SLEEVE
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 11357882
• MDR Text Key: 232836628
• Report Number: 1818910-2021-03488
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 02/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2012
• Device Catalogue Number: 999800312
• Device Lot Number: 2368596
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Treatment: ADAPTER SLEEVES 12/14 +2; ASR ACETABULAR CUPS 50; ASR UNI FEMORAL IMPL SIZE 45; SUMMIT POR TAPER SZ5 STD OFF; ADAPTER SLEEVES 12/14 +2; ASR ACETABULAR CUPS 50; ASR UNI FEMORAL IMPL SIZE 45; SUMMIT POR TAPER SZ5 STD OFF
• Patient Outcome(s): Required Intervention