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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 ASR HIP SYSTEM : HIP METAL FEMORAL HEADS

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DEPUY INTERNATIONAL LTD - 8010379 TOTAL ASR FEM IMP SIZE 53 ASR HIP SYSTEM : HIP METAL FEMORAL HEADS Back to Search Results
Catalog Number 999804653
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cyst(s) (1800); Foreign Body Reaction (1868); Pain (1994); Limb Fracture (4518); Unspecified Tissue Injury (4559); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/16/2011
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). 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. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Litigation and medical records received. Litigation alleges pain and cyst formation. After review of medical records, the patient was revised due to failed left hip resurfacing. Operative notes indicated that here was some metalosis. There was a break at the bases of the femoral component. There was a very large cyst involving all of the greater trochanter. There was a hole through the anterior superior region of the greater trochanter though the cortex, however, the main cortex was intact. Doi: (b)(6) 2007, dor: (b)(6) 2011, left hip.
 
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Brand NameTOTAL ASR FEM IMP SIZE 53
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 Key13343705
MDR Text Key284373492
Report Number1818910-2022-01608
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
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup
Report Date 01/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/25/2022
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 Received02/28/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/03/2007
Is the Device Single Use? No
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: 01/25/2022 Patient Sequence Number: 1
Treatment
ASR ACETABULAR IMPLANT 60; TOTAL ASR FEM IMP SIZE 53
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