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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK HIP ACETABULAR LINER POLY DURALOC
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DEPUY ORTHOPAEDICS INC US UNK HIP ACETABULAR LINER POLY DURALOC Back to Search Results
Catalog Number UNK HIP ACETABULAR LINER POLY
Device Problem Naturally Worn (2988)
Patient Problem Insufficient Information (4580)
Event Date 12/03/2020
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
It was reported that the duraloc hylamer liner was revised for poly wear.Doi: unknown.Dor: (b)(6) 2020; left 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 LINER POLY DURALOC
Type of Device
ACETABULAR LINER
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key11027993
MDR Text Key222064141
Report Number1818910-2020-27176
Device Sequence Number1
Product Code KWY
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 12/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNK HIP ACETABULAR LINER POLY
Was Device Available for Evaluation? No
Date Manufacturer Received01/08/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
UNK HIP ACETABULAR CUP DURALOC; UNKNOWN HIP FEMORAL HEAD; UNK HIP ACETABULAR CUP DURALOC; UNKNOWN HIP FEMORAL HEAD
Patient Outcome(s) Required Intervention;
Patient Age79 YR
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