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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. 8010379 TOTAL ASR ACET IMP SIZE 50; HIP ACETABULAR CUP
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DEPUY INTERNATIONAL LTD. 8010379 TOTAL ASR ACET IMP SIZE 50; HIP ACETABULAR CUP Back to Search Results
Catalog Number 999804550
Device Problems Loose or Intermittent Connection (1371); Loss of Osseointegration (2408); Osseointegration Problem (3003); Appropriate Term/Code Not Available (3191)
Patient Problems Host-Tissue Reaction (1297); Inflammation (1932); Necrosis (1971); Pain (1994); Anxiety (2328); Distress (2329); Injury (2348); Joint Disorder (2373); Ambulation Difficulties (2544); No Information (3190); No Code Available (3191)
Event Date 03/04/2017
Event Type  Injury  
Manufacturer Narrative
This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.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
Jun 28, 2017: legal claim and response received.Legal claim reported that the patient had a serious dysfunction of the right hip because of the implants.Claim states that the patient's chromium level was above 7 ppb.There are no medical records provided.
 
Manufacturer Narrative
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
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Reason(s) for revision: pain and component loosening.
 
Manufacturer Narrative
Legal claim and response received.Legal claim reported that the patient had a serious dysfunction of the right hip because of the implants.Claim states that the patient's chromium level was above 7 ppb.There are no medical records provided the reported event has been evaluated and will be monitored.Depuy considers the investigation closed at this time.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 will be filed as appropriate.
 
Event Description
In addition to what were previously alleged, claim letter alleges that biopsy after revision shows fragment of fibromuscular tissue showing widespread chronic necrotizing and granulomatous inflammation.Claim letter also alleges irreversible damages, anxiety, moral distress, walking difficulties and fluid build-up due to toxic metals.Doi: (b)(6) 2009; dor: (b)(6) 2017; 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.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 capa001226.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, a follow-up medwatch will be filed as appropriate.
 
Event Description
In addition to what were previously alleged, claim letter alleges bone and muscle injury due to subsequent replacement of prosthesis muscle had lost attachment to the bone, tumor, malaise and psychophysical imbalance of the patient.
 
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.
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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 will be filed as appropriate.
 
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Brand Name
TOTAL ASR ACET IMP SIZE 50
Type of Device
HIP ACETABULAR CUP
Manufacturer (Section D)
DEPUY INTERNATIONAL LTD. 8010379
st. anthony's rd
leeds LS11 8 DT
UK  LS11 8 DT
MDR Report Key6691040
MDR Text Key79201952
Report Number1818910-2017-20664
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 distributor,foreign,health pr
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 06/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/06/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number999804550
Device Lot Number2798451
Was Device Available for Evaluation? No
Date Manufacturer Received12/23/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberZ-1749/1816-2011
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age64 YR
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