MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ASR ACETABULAR CUPS 60 ASR HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number 999800760

Device Problems Corroded (1131); Naturally Worn (2988)

Patient Problems Cyst(s) (1800); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994)

Event Date 06/10/2014

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

Asr claim and medical records received. After review of medical records patient was revised to addressed painful left hip with metal on metal bearing with trunnion metallosis that most likely cause of the irritation. Mri showed a large cyst like lesions compatible with the metal on metal bearing. There was not an abnormal amount of wear, although there were some small burnished marks on the femoral head. The trunnion was quite coated with a thick black residue. Acetabular cup was solidly fixed, lightly burnished but not scratched. Doi: (b)(6) 2006. Dor: (b)(6) 2014, left hip.

• Brand Name: ASR ACETABULAR CUPS 60
• 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: 12547128
• MDR Text Key: 273790570
• Report Number: 1818910-2021-21391
• 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

• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 09/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 05/21/2011
• Device Catalogue Number: 999800760
• Device Lot Number: 2159203
• 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: 10/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2006
• Is the Device Single Use?: No
• 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: 09/29/2021 Patient Sequence Number: 1

Treatment

ADAPTER SLEEVES 12/14 +2; ASR ACETABULAR CUPS 60; ASR UNI FEMORAL IMPL SIZE 53; CORAIL2 LAT COXA VARA SIZE 13