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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. 8010379 DEPUY ASR XL FEM IMP SIZE 46; ASR HIP SYSTEM : HIP METAL FEMORAL HEADS
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DEPUY INTERNATIONAL LTD. 8010379 DEPUY ASR XL FEM IMP SIZE 46; ASR HIP SYSTEM : HIP METAL FEMORAL HEADS Back to Search Results
Catalog Number 999890146
Device Problem Device Dislodged or Dislocated (2923)
Patient Problems Foreign Body Reaction (1868); Inflammation (1932); Pain (1994); Tissue Damage (2104); Injury (2348); Joint Dislocation (2374); Osteolysis (2377); Inadequate Osseointegration (2646); Limited Mobility Of The Implanted Joint (2671); Fibrosis (3167); No Code Available (3191)
Event Date 03/07/2018
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4).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.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.Investigation summary: the asr platform was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive.Further investigation of this individual incident will not be undertaken.The investigation regarding the root cause(s) and/or corrective actions was conducted under mdd capa- (b)(4).Ongoing post market surveillance is conducted per our procedures for this product.
 
Event Description
(b)(4) claim letter record received.Awaiting for english translation.Once translation is available, this complaint will be updated.
 
Event Description
Patient has not undergone revision of the right hip.
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand Name
DEPUY ASR XL FEM IMP SIZE 46
Type of Device
ASR HIP SYSTEM : HIP METAL FEMORAL HEADS
Manufacturer (Section D)
DEPUY INTERNATIONAL LTD. 8010379
st. anthony's rd
leeds LS11 8 DT
UK  LS11 8 DT
MDR Report Key8807882
MDR Text Key151606117
Report Number1818910-2019-98806
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 06/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number999890146
Device Lot Number2910972
Was Device Available for Evaluation? No
Date Manufacturer Received12/18/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberZ-1749/1816-2011
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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