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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 45; ASR HIP SYSTEM : HIP METAL FEMORAL HEADS
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DEPUY INTERNATIONAL LTD - 8010379 TOTAL ASR FEM IMP SIZE 45; ASR HIP SYSTEM : HIP METAL FEMORAL HEADS Back to Search Results
Catalog Number 999803845
Device Problem Naturally Worn (2988)
Patient Problems Pain (1994); No Code Available (3191)
Event Date 01/12/2020
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4).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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
(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
Asr index/revision; asr resurfacing; left hip; reason for revision: pain, chromium level 3.05 ppb, likely due to metal debris.Doi: (b)(6) 2005; dor: (b)(6) 2020 (left 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.Product complaint # (b)(4).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 (b)(4).Ongoing post market surveillance is conducted per our procedures for this product.Device history lot null device history batch null device history review null if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
This is to capture the updated harm and codes.
 
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.Udi: (b)(4).H6 patient code: no code available (3191) used to capture the device revision or replacement.
 
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Brand Name
TOTAL ASR FEM IMP SIZE 45
Type of Device
ASR HIP SYSTEM : HIP METAL FEMORAL HEADS
Manufacturer (Section D)
DEPUY INTERNATIONAL LTD - 8010379
st. anthony's road
leeds LS11 8DT
UK  LS11 8DT
MDR Report Key9647822
MDR Text Key185303507
Report Number1818910-2020-03606
Device Sequence Number1
Product Code KXA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup
Report Date 01/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number999803845
Device Lot Number1220187
Was Device Available for Evaluation? No
Date Manufacturer Received05/12/2020
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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