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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ASR ACETABULAR CUPS 50 ASR HIP SYSTEM : HIP METAL ACETABULAR CUPS

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DEPUY INTERNATIONAL LTD - 8010379 ASR ACETABULAR CUPS 50 ASR HIP SYSTEM : HIP METAL ACETABULAR CUPS Back to Search Results
Catalog Number 999800750
Device Problems Loss of Osseointegration (2408); Naturally Worn (2988)
Patient Problems Foreign Body Reaction (1868); Pain (1994); Injury (2348); Inadequate Osseointegration (2646); No Code Available (3191)
Event Date 06/18/2018
Event Type  Injury  
Manufacturer Narrative

Product complaint #: (b)(4). Initial reporter 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 ACETABULAR CUPS 50
Type of DeviceASR HIP SYSTEM : HIP METAL ACETABULAR CUPS
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 Key10704560
MDR Text Key212078951
Report Number1818910-2020-22729
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 Received10/20/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/28/2013
Device Catalogue Number999800750
Device LOT Number2559704
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 Manufactured03/13/2008
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: 10/20/2020 Patient Sequence Number: 1
Treatment
3L92602; ADAPTER SLEEVES 12/14 +5; ASR UNI FEMORAL IMPL SIZE 45
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