MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 UNKNOWN HIP ACETABULAR CUP

Catalog Number UNK HIP ACETABULAR CUP

Device Problems Off-Label Use (1494); Naturally Worn (2988)

Patient Problems Edema (1820); Foreign Body Reaction (1868); Necrosis (1971); Sepsis (2067); Osteolysis (2377); Test Result (2695); No Code Available (3191)

Event Date 11/27/2018

Event Type  Injury  

Manufacturer Narrative

(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 medical records received. After review of medical records, the patient was revised to address a failed right total hip arthroplasty due to metallosis, elevated metal ions with sepsis. Intraoperatively, approximately 100 ml of abundant cloudy fluid poured out from the capsule. The capsule was consistent with adverse reaction to metal debris. The femoral component was stable but there was a necrotic, osteolytic lesion. The patient was noted to be about 4mm short preoperatively. The cup was noted to have 59 degrees of inclination with significant anteversion. However, the surgeon did not consider the cup to be malpositioned given the patient's severe spinopelvic mal-alignment. The surgeon elected to retain the asr xl cup and the stem. Doi: (b)(6) 2009. Dor: (b)(6) 2018. (right hip).

• Brand Name: UNKNOWN HIP ACETABULAR CUP
• Type of Device: HIP ACETABULAR CUP
• 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: 9647892
• MDR Text Key: 188809746
• Report Number: 1818910-2020-03609
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (Y/N): N
• Reporter Country Code: US
• 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: 01/17/2020

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 01/30/2020
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device Catalogue Number: UNK HIP ACETABULAR CUP
• 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: 04/22/2020
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Is The Device Single Use?: No Answer Provided
• 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: 01/30/2020 Patient Sequence Number: 1