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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 47 ASR HIP SYSTEM : HIP METAL FEMORAL HEADS

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DEPUY INTERNATIONAL LTD - 8010379 ASR UNI FEMORAL IMPL SIZE 47 ASR HIP SYSTEM : HIP METAL FEMORAL HEADS Back to Search Results
Catalog Number 999890247
Device Problem Naturally Worn (2988)
Patient Problems Cyst(s) (1800); Death (1802); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Distress (2329); Discomfort (2330); Injury (2348); Ambulation Difficulties (2544); Test Result (2695)
Event Date 04/15/2019
Event Type  Death  
Manufacturer Narrative
(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
It was reported that the patient had an asr cup,sleeve and head done over 10 years ago in (b)(6). The surgeon took out asr head sleeve and cup, and put in new pinnacle multihole shelll, screw, liner and head. Doi: over 10 years ago; dor: (b)(6) 2019; left hip.
 
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Brand NameASR UNI FEMORAL IMPL SIZE 47
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 Key10022886
MDR Text Key189825448
Report Number1818910-2020-11638
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 company representative,consum
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 04/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/04/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2019
Device Catalogue Number999890247
Device Lot Number2952930
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 Received07/20/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/07/2009
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: 05/04/2020 Patient Sequence Number: 1
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