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U.S. Department of Health and Human Services

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

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DEPUY INTERNATIONAL LTD - 8010379 UNKNOWN HIP ACETABULAR CUP Back to Search Results
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).

 
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Brand NameUNKNOWN HIP ACETABULAR CUP
Type of DeviceHIP 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 Key9647892
MDR Text Key188809746
Report Number1818910-2020-03609
Device Sequence Number1
Product Code KWA
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
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 Received01/30/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNK 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 Received04/22/2020
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 NumberZ-1749/1816-2011

Patient TREATMENT DATA
Date Received: 01/30/2020 Patient Sequence Number: 1
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