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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP ACETABULAR CUP
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DEPUY ORTHOPAEDICS INC US UNKNOWN HIP ACETABULAR CUP Back to Search Results
Catalog Number UNK HIP ACETABULAR CUP
Device Problem Loss of Osseointegration (2408)
Patient Problems Inadequate Osseointegration (2646); No Code Available (3191)
Event Date 08/10/2020
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
It was reported that patient was revised to address loosening of the cup at bone to implant interface.Pulled cup out of acetabulum.Doi: (b)(6) 2020, dor: (b)(6) 2020, affected side: 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
UNKNOWN HIP ACETABULAR CUP
Type of Device
HIP ACETABULAR CUP
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key10436945
MDR Text Key203874215
Report Number1818910-2020-18531
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 08/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/21/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNK HIP ACETABULAR CUP
Was Device Available for Evaluation? No
Date Manufacturer Received08/27/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
36/1.5 CERAMIC HEAD; 36/56 +4N LINER; 56 100 GRIPTION CUP; 36/1.5 CERAMIC HEAD; 36/56 +4N LINER; 56 100 GRIPTION CUP
Patient Outcome(s) Required Intervention;
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