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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 51 ASR HIP SYSTEM : HIP METAL FEMORAL HEADS

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DEPUY INTERNATIONAL LTD - 8010379 ASR UNI FEMORAL IMPL SIZE 51 ASR HIP SYSTEM : HIP METAL FEMORAL HEADS Back to Search Results
Catalog Number 999890251
Device Problems Device Dislodged or Dislocated (2923); Naturally Worn (2988); Noise, Audible (3273)
Patient Problems Foreign Body Reaction (1868); Inflammation (1932); Pain (1994); No Code Available (3191); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 05/12/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4). 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
Asr litigation record received. Patient alleges that the acetabular cup eventually detached, disconnected, created metallic debris, and/or loosened from patient's acetabulum, grinding, and clicking for several months, caused patient's severe pain, and inhibited ability to walk. Doi: (b)(6) 2008 - dor: (b)(6) 2020 (left hip).
 
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Brand NameASR UNI FEMORAL IMPL SIZE 51
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)
LEEDS MFG & MATERIAL WAREHOUSE
st anthonys road
leeds LS11 8DT
UK LS11 8DT
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key10321266
MDR Text Key200315323
Report Number1818910-2020-16824
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K04062
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
Report Date 07/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2012
Device Catalogue Number999890251
Device Lot Number2521169
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 Received05/24/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/21/2007
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: 07/24/2020 Patient Sequence Number: 1
Treatment
UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP FEMORAL AUGMENT; UNKNOWN HIP FEMORAL HEAD; UNKNOWN HIP FEMORAL STEM
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