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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP ACETABULAR LINERS

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DEPUY ORTHOPAEDICS INC US UNKNOWN HIP ACETABULAR LINERS Back to Search Results
Catalog Number UNK HIP ACETABULAR LINER
Device Problems Naturally Worn (2988); Noise, Audible (3273)
Patient Problems Fatigue (1849); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); No Code Available (3191)
Event Date 12/05/2013
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

Initial total hip surgery was performed on (b)(6) 2011 where a depuy pinnacle porocoat acetabular shell sector ii, a depuy summit tapered hip stem with porocoat and a depuy articuleze metal on metal femoral head was inserted. A legal claim was received on august 13, 2019 which indicated that the patient had the following symptoms after her total right hip surgery on (b)(6) 2011; persistent pain, squeaking of implant, fatigue, decline of vision, elevated levels chromium and cobalt, metallosis and a pseudo tumor in her thigh. Revision surgery was performed on (b)(6) 2013 to replace the metal on metal hip implant with a polyethylene and ceramic hip implant, also to excise the pseudotumor and clean out metal debris. Doi: (b)(6) 201. Dor: (b)(6) 2013, (right hip).

 
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Brand NameUNKNOWN HIP ACETABULAR LINERS
Type of DeviceHIP ACETABULAR LINERS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46582 0988
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester, PA 19380-0988
6107428552
MDR Report Key8956407
MDR Text Key156312975
Report Number1818910-2019-102858
Device Sequence Number1
Product Code LZO
Combination Product (Y/N)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,OTHER
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 08/13/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/03/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNK HIP ACETABULAR LINER
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/06/2019
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

Patient TREATMENT DATA
Date Received: 09/03/2019 Patient Sequence Number: 1
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