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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL HEAD

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DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL HEAD Back to Search Results
Catalog Number UNK HIP FEMORAL HEAD
Device Problem Naturally Worn (2988)
Patient Problems Hypersensitivity/Allergic reaction (1907); Local Reaction (2035)
Event Date 11/10/2015
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

Unf and medical records received. After review of medical records patient was revised to address failed left total hip arthroplasty secondary to metal wear and hypersensitivity. Revision notes reported that there was metallic stained synovial fluid present and dissection was made down to the it band, which showed evidence of penetration by a large metallic pseudotumor. There was significant hypertrophic synovium, which was then excised. Ah of this was metallic stained. Doi: unknown. Dor: (b)(6) 2015; (left hip). The patient has bilateral hip implants, please see (b)(4) for the right hip.

 
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Brand NameUNKNOWN HIP FEMORAL HEAD
Type of DeviceHIP FEMORAL HEAD
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS 1818910
700 orthopaedic dr
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key11024712
MDR Text Key221999547
Report Number1818910-2020-27123
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 CONSUMER,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/07/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/16/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNK HIP FEMORAL HEAD
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 Received01/08/2021
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

Patient TREATMENT DATA
Date Received: 12/16/2020 Patient Sequence Number: 1
Treatment
UNKNOWN HIP ACETABULAR LINERS; UNKNOWN HIP FEMORAL HEAD
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