MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ASR TAP SLV ADAP 12/14 -1; ASR HIP SYSTEM : HIP FEMORAL SLEEVE

Catalog Number 999890353

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

Patient Problems Stroke/CVA (1770); Foreign Body Reaction (1868); Pain (1994); Loss of Range of Motion (2032); Discomfort (2330); Ambulation Difficulties (2544); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/28/2018

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).Initial reporter occupation: lawyer.(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 litigation records received patient was revised to address metallosis.Patient has stiffness in the right hip that causes to limp, had mild difficulty with slight trendelenburg limp on the right.Patient had elevated cobalt levels of 9.9 and patient had stroke.Doi: (b)(6) 2008 - dor: (b)(6) 2018 (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.

• Brand Name: ASR TAP SLV ADAP 12/14 -1
• 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: 11529467
• MDR Text Key: 241063837
• Report Number: 1818910-2021-05570
• 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: other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2013
• Device Catalogue Number: 999890353
• Device Lot Number: 2748304
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Treatment: ASR ACETABULAR CUPS 60; ASR TAP SLV ADAP 12/14 -1; ASR UNI FEMORAL IMPL SIZE 53; SUMMIT POR TAPER SZ7 HI OFF; ASR ACETABULAR CUPS 60; ASR TAP SLV ADAP 12/14 -1; ASR UNI FEMORAL IMPL SIZE 53; SUMMIT POR TAPER SZ7 HI OFF
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Weight: 113