MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ASR ACETABULAR CUPS 54 ASR HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number 999800754

Device Problem Noise, Audible (3273)

Patient Problems Foreign Body Reaction (1868); Necrosis (1971); Loss of Range of Motion (2032); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/07/2020

Event Type  Injury  

Event Description

Left tha completed due to osteoarthritis. A depuy asr head, asr cup, and taper sleeve adapter were used. Patient completed of audible noise and popping in the hip. Revision completed secondary to adverse metal-on-metal reactions and cobalt chromium toxicity. Patient had moderate alval limited to the capsule with small amounts of tissue necrosis around the capsule. Doi: (b)(6) 2007; dor: (b)(6) 2020; left hip.

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.

• Brand Name: ASR ACETABULAR CUPS 54
• 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
• 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: 13190901
• MDR Text Key: 283394221
• Report Number: 1818910-2022-00387
• 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: 01/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 999800754
• Device Lot Number: 2316515
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 01/07/2022 Patient Sequence Number: 1

Treatment

ADAPTER SLEEVE 11/13 +0; ASR UNI FEMORAL IMPL SIZE 47; S-ROM*SLEEVE PRX ZTT, 18D-LRG; SROM STM STD 36+12L 13X18