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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 53 METAL FEMORAL HEAD

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DEPUY INTERNATIONAL LTD - 8010379 ASR UNI FEMORAL IMPL SIZE 53 METAL FEMORAL HEAD Back to Search Results
Catalog Number 999890253
Device Problems Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cyst(s) (1800); Foreign Body Reaction (1868); Pain (1994); Scar Tissue (2060); Distress (2329); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 11/01/2020
Event Type  Injury  
Event Description
Litigation letter received. Litigation alleges pain, suffering, excessive levels of chormium and cobalt, and emotional distress as well as economic loss and punitive damages. Doi: (b)(6) 2007, dor: (b)(6) 2020, left hip.
 
Manufacturer Narrative
Product complaint # (b)(4). Investigation summary: no device associated with this report was received for examination. This hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive. Depuy considers the investigation closed. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary. 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.
 
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Brand NameASR UNI FEMORAL IMPL SIZE 53
Type of DeviceMETAL FEMORAL HEAD
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 Key13337285
MDR Text Key285544923
Report Number1818910-2022-01513
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 Other
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 01/24/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/24/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number999890253
Device Lot Number2351423
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received03/29/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/14/2007
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: 01/24/2022 Patient Sequence Number: 1
Treatment
UNK HIP ACETABULAR CUP ASR; UNK HIP FEMORAL SLEEVE ASR; UNKNOWN HIP FEMORAL STEM
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