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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 45 ASR HIP SYSTEM : HIP METAL FEMORAL HEADS

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DEPUY INTERNATIONAL LTD - 8010379 ASR UNI FEMORAL IMPL SIZE 45 ASR HIP SYSTEM : HIP METAL FEMORAL HEADS Back to Search Results
Catalog Number 999890245
Device Problem Naturally Worn (2988)
Patient Problems Foreign Body Reaction (1868); Pain (1994); Injury (2348); No Code Available (3191)
Event Date 06/18/2018
Event Type  Injury  
Manufacturer Narrative

Product complaint # (b)(4). Occupation: lawyer. (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

 
Event Description

Medical record received. After review of medical record, patient was revised to address aseptic loosening, pain, and wear. Revision notes stated that the head was removed. Acetabular component was not overtly loose at the bone implant interface but was removed. Bone loss was noted. Operative findings noted that acetabular implant was loose and noted metallosis. Doi: (b)(6) 2008 - dor: (b)(6) 2018 (right hip).

 
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Brand NameASR UNI FEMORAL IMPL SIZE 45
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 Key10697459
MDR Text Key211893496
Report Number1818910-2020-22727
Device Sequence Number1
Product Code KWA
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK040627
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 10/02/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/19/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/30/2013
Device Catalogue Number999890245
Device LOT Number2597139
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 Received11/16/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/12/2008
Is The Device Single Use? No
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: 10/19/2020 Patient Sequence Number: 1
Treatment
3L92602; ADAPTER SLEEVES 12/14 +5; ASR ACETABULAR CUPS 50
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