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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 49 ASR HIP SYSTEM : HIP METAL FEMORAL HEADS

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DEPUY INTERNATIONAL LTD - 8010379 ASR UNI FEMORAL IMPL SIZE 49 ASR HIP SYSTEM : HIP METAL FEMORAL HEADS Back to Search Results
Catalog Number 999890249
Device Problem Naturally Worn (2988)
Patient Problems Cyst(s) (1800); Edema (1820); Foreign Body Reaction (1868); Pain (1994); Osteolysis (2377); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); No Code Available (3191)
Event Date 11/26/2019
Event Type  Injury  
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 asr head and adaptor were removed and were replaced with 28mm head and competitor's polar dual mobility liner to remove the metal on metal articulation. Doi: unknown; dor: (b)(6) 2019; left hip.
 
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Brand NameASR UNI FEMORAL IMPL SIZE 49
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 Key9938479
MDR Text Key187029365
Report Number1818910-2020-10450
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,Followup,Followup
Report Date 11/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2012
Device Catalogue Number999890249
Device Lot Number2391775
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 Received03/23/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/31/2007
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: 04/08/2020 Patient Sequence Number: 1
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