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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 TOTAL ASR FEM IMP SIZE 53 METAL FEMORAL HEAD

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DEPUY INTERNATIONAL LTD - 8010379 TOTAL ASR FEM IMP SIZE 53 METAL FEMORAL HEAD Back to Search Results
Catalog Number 999804653
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cyst(s) (1800); Pain (1994); Ambulation Difficulties (2544); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 09/06/2011
Event Type  Injury  
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. No 510(k) number provided because this implant is sold internationally with different indications for use; it is currently sold in the us under a different part number. The correction/removal reporting number listed applies to the corresponding product code sold domestically. (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
Litigation record received. Patient alleges pain, develop cyst around the stem, an x-ray confirmed failure of the femoral component and sustained a fracture at the base of the femoral component. After revision, patient continued to experience pain, developed cyst as a result of metal and patient underwent further surgery for removal of bony exostosis on (b)(6) 2015 but it is unknown what products were removed and implanted. Patient continued to experienced pain and suffering and affect quality of life and ability to earn income and difficulty with walking and continued to have elevated levels of heavy metals in patient's bloodstream but it is unknown which products were removed during first and second revision and it is unknown if the products implanted during revisions were depuy. Doi: (b)(6) 2007 - dor: (b)(6) 2011 (left hip).
 
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Brand NameTOTAL ASR FEM IMP 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 Key12848691
MDR Text Key281071606
Report Number1818910-2021-25773
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Consumer
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup
Report Date 11/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/31/2012
Device Catalogue Number999804653
Device Lot Number2471292
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received03/16/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/03/2007
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: 11/19/2021 Patient Sequence Number: 1
Treatment
UNK HIP ACETABULAR CUP ASR; UNK HIP FEMORAL HEAD METAL ASR; UNKNOWN HIP FEMORAL AUGMENT; UNKNOWN HIP FEMORAL STEM
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