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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ASR ACETABULAR CUPS 50; ASR HIP SYSTEM : HIP METAL ACETABULAR CUPS
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DEPUY INTERNATIONAL LTD - 8010379 ASR ACETABULAR CUPS 50; ASR HIP SYSTEM : HIP METAL ACETABULAR CUPS Back to Search Results
Catalog Number 999800750
Device Problems Loss of Osseointegration (2408); Device Dislodged or Dislocated (2923); Naturally Worn (2988)
Patient Problems Foreign Body Reaction (1868); Pain (1994); Synovitis (2094); Discomfort (2330); Joint Dislocation (2374); Osteolysis (2377); Inadequate Osseointegration (2646); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191); Physical Asymmetry (4573)
Event Date 06/19/2018
Event Type  Injury  
Manufacturer Narrative
(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
Patient was revised to address loosening of the cup at the bone to implant interface.It was also reported that the cup, head and sleeve were removed.Doi: unknown; dor: (b)(6) 2018; left hip.
 
Manufacturer Narrative
Product complaint #
=
> pc-(b)(4).Investigation summary
=
> this hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.Further investigation of this individual incident will not be undertaken.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.
 
Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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 report, a follow-up report will be filed as appropriate.No code available is used to capture emotional distress and device revision or replacement.
 
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.
 
Event Description
Litigation alleges pain, discomfort, interfer adl and emotional distress.Doi: (b)(6) 2010: dor: (b)(6) 2018; left hip.
 
Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H6 patient code: no code available (3191) used to capture the emotional distress and blood heavy metal increased.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
 
Event Description
After review of the medical records the patient was revised to address loosening of the cup, dislocation, resulting to pain and limited activities of daily living.Operative finding reported intraoperative synovial fluid with 800 white blood cells and 85% neutrophils, there were evidence of acute inflammation and was some synovitis with metal staining.Acetabular component was loosed.There is also osteolysis along the acetabulum.Chromium and cobalt are above 7 (no unit provided).Doi: (b)(6) 2010; dor: (b)(6) 2018; left hip.
 
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.
 
Manufacturer Narrative
Product complaint (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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 report, a follow-up report will be filed as appropriate.
 
Event Description
After review of the medical records and in addition to what was previously reported the patient was revised due leg length discrepancy, limited mobility/adl, cup disassociated from the femoral head, stem had some varus alignment.Operative note reported there is a fair amount of bursal tissue and was debrided, abductor and iliotibial attachment is thin, stained synovitis was also debrided.It was also noted that there was a worn portion of the superior roof of the cup, cup was loose and displaced.Also worn in the medical wall, osteolysis along the acetabulum.Clinical visit reported dislodgement of the cup and head and had soft tissue reaction.Doi: (b)(6), 2006; dor: (b)(6), 2018; left hip.
 
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.Update 9-jun-2021: the investigation was re-opened upon receipt of additional information.The new information does not affect the existing investigations.Device history lot: previous investigations that have included device history reviews since the asr platform was launched have shown no indication of deviations or anomalies with regard to material, manufacturing, or inspection.Therefore, no device history record (dhr) review for this individual asr component will be carried out at this point in time.
 
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Brand Name
ASR ACETABULAR CUPS 50
Type of Device
ASR HIP SYSTEM : HIP METAL ACETABULAR CUPS
Manufacturer (Section D)
DEPUY INTERNATIONAL LTD - 8010379
st. anthony's road
leeds LS11 8DT
UK  LS11 8DT
MDR Report Key7682056
MDR Text Key113785777
Report Number1818910-2018-64298
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
PMA/PMN Number
K040627
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 06/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number999800750
Device Lot Number2142198
Was Device Available for Evaluation? No
Date Manufacturer Received06/09/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberZ-1749/1816-2011
Patient Sequence Number1
Treatment
ADAPTER SLEEVE 11/13 +3; ASR UNI FEMORAL IMPL SIZE 45; UNKNOWN HIP FEMORAL STEM
Patient Outcome(s) Required Intervention;
Patient Age67 YR
Patient Weight102
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