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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ASR UNI FEMORAL IMPL SIZE 46 ASR HIP SYSTEM : HIP METAL FEMORAL HEADS

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DEPUY INTERNATIONAL LTD - 8010379 ASR UNI FEMORAL IMPL SIZE 46 ASR HIP SYSTEM : HIP METAL FEMORAL HEADS Back to Search Results
Catalog Number 999890246
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Necrosis (1971); Unspecified Tissue Injury (4559)
Event Date 12/14/2020
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
Medical records received. After review of medical record, it was reported that the patient was revised for failed left tha with recalled metal on metal on metal design with massive pelvic associated bone loose and pseudotumor. Operative notes reported that there was a chronic non-union of greater trochanteric fracture. There was a dense dark gray organized mass protruding from the posterior pseudo capsule. There were areas within the mass of frank necrosis. Debrided intracapsular tissue that was similarly consistent with pseudotumor. There was gross evidence of taper junction corrosion with black debris along the trunnion. There was extensive black necrotic pastry debris behind the cup. The anterior column was largely absent down into a significant portion of the pubic root. There was essentially no anterior wall. There was a significant cavity extending up the ilium similarly filled with black pasty debris that was debrided. Doi: (b)(6) 2009, dor: (b)(6) 2020, left hip.
 
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Brand NameASR UNI FEMORAL IMPL SIZE 46
Type of DeviceASR HIP SYSTEM : HIP METAL FEMORAL HEADS
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 Key12547659
MDR Text Key273807970
Report Number1818910-2021-21422
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K040627
Number of Events Reported1
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 Received09/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/30/2018
Device Catalogue Number999890246
Device Lot Number2783222
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 Received10/25/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/24/2008
Is the Device Single Use? Yes
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: 09/29/2021 Patient Sequence Number: 1
Treatment
ADAPTER SLEEVE 11/13 +0; ASR ACETABULAR CUPS 52; ASR UNI FEMORAL IMPL SIZE 46; S-ROM*SLEEVE PRX ZTT, 16D-SML; SROM STM ST,36+6L NK,11X16X150
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