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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ASR ACETABULAR CUPS 58 ASR HIP SYSTEM : HIP METAL ACETABULAR CUPS
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DEPUY INTERNATIONAL LTD - 8010379 ASR ACETABULAR CUPS 58 ASR HIP SYSTEM : HIP METAL ACETABULAR CUPS Back to Search Results
Catalog Number 999800758
Device Problems Loss of Osseointegration (2408); Device Dislodged or Dislocated (2923); Naturally Worn (2988); Noise, Audible (3273)
Patient Problems Foreign Body Reaction (1868); Inflammation (1932); Pain (1994); Inadequate Osseointegration (2646); No Code Available (3191); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 05/12/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4). Occupation: lawyer. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Asr litigation record received. Patient alleges that the acetabular cup eventually detached, disconnected, created metallic debris, and/or loosened from patient's acetabulum, grinding, and clicking for several months, caused patient's severe pain, and inhibited ability to walk. Doi: (b)(6) 2008 - dor: (b)(6) 2020 (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. H10 additional narrative: added: h6 (device).
 
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Brand NameASR ACETABULAR CUPS 58
Type of DeviceASR 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 Key10321277
Report Number1818910-2020-16822
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 07/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number999800758
Device Lot Number2441607
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/24/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberZ-1749/1816-2011
Patient Age68 YR
Patient Treatment(s)
ASR ACETABULAR CUPS 58; ASR ACETABULAR CUPS 58; ASR UNI FEMORAL IMPL SIZE 51; SUMMIT DUOFIX TAP SZ5 STD OFF; UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP FEMORAL AUGMENT; UNKNOWN HIP FEMORAL HEAD; UNKNOWN HIP FEMORAL STEM; UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP FEMORAL AUGMENT; UNKNOWN HIP FEMORAL HEAD; UNKNOWN HIP FEMORAL STEM
Patient Outcome(s) Required Intervention;
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