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

Catalog Number 999800312

Device Problem Degraded (1153)

Patient Problems Foreign Body Reaction (1868); Swelling/ Edema (4577)

Event Date 08/30/2021

Event Type  Injury  

Event Description

Asr claim and medical records received. After review of the medical records, the patient was revised to address failed left thr with placement of dual mobility component. Operative note reported a large amount of clear to slightly yellow tinted fluid within the joint. There was corrosion of mild degree at the trunnion of the femoral component and femoral prosthetic head. Doi: (b)(6) 2009; dor: (b)(6) 2021 left hip.

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.

• 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
• Manufacturer (Section G): DEPUY INT'L LTD. 8010379; st anthonys road; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14166526
• MDR Text Key: 289735059
• Report Number: 1818910-2022-07182
• 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: Other

Reporter Occupation

• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 04/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 01/31/2014
• Device Catalogue Number: 999800312
• Device Lot Number: 2824296
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1749/1816-2011

Patient Treatment Data

Date Received: 04/21/2022 Patient Sequence Number: 1

Treatment

ADAPTER SLEEVES 12/14 +2; ASR ACETABULAR CUPS 52; ASR UNI FEMORAL IMPL SIZE 46; CORAIL AMT COLLAR SIZE 9