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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 UNK HIP ACETABULAR CUP DURALOC
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DEPUY INTERNATIONAL LTD - 8010379 UNK HIP ACETABULAR CUP DURALOC Back to Search Results
Catalog Number UNK HIP ACETABULAR CUP DURALOC
Device Problems Osseointegration Problem (3003); Migration (4003)
Patient Problem Inadequate Osseointegration (2646)
Event Date 11/23/2020
Event Type  Injury  
Manufacturer Narrative
Product complaint #: (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
The patient was revised due to acetabular cup migration and loosening at bone to implant interface.Doi: unknown, dor: (b)(6) 2020, right hip.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.
 
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Brand Name
UNK HIP ACETABULAR CUP DURALOC
Type of Device
HIP ACETABULAR CUP
Manufacturer (Section D)
DEPUY INTERNATIONAL LTD - 8010379
st. anthony's road
leeds LS11 8DT
UK  LS11 8DT
MDR Report Key10980335
MDR Text Key220641329
Report Number1818910-2020-26661
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 company representative,health
Type of Report Initial,Followup
Report Date 11/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNK HIP ACETABULAR CUP DURALOC
Was Device Available for Evaluation? No
Date Manufacturer Received01/06/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
(28 METAL HEAD); (DURALOC); UNK HIP LOCKING RING
Patient Outcome(s) Required Intervention;
Patient Age85 YR
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