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 Adhesion(s) (1695); Hypersensitivity/Allergic reaction (1907); Pain (1994); Distress (2329); Osteolysis (2377); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

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.

• 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
• Manufacturer (Section G): DEPUY INT'L LTD. 8010379; st anthonys road; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12365662
• Report Number: 1818910-2021-18622
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040627
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other

Reporter Occupation

• 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

• Device Expiration Date: 04/30/2014
• Device Catalogue Number: 999890353
• Device Lot Number: 2906766
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Treatment(s): 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