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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP ACETABULAR LINERS
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DEPUY ORTHOPAEDICS INC US UNKNOWN HIP ACETABULAR LINERS Back to Search Results
Catalog Number UNK HIP ACETABULAR LINER
Device Problem Fracture (1260)
Patient Problems Pain (1994); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
Event Date 08/08/2020
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
The patient was revised to address an increased pain in hip and could not move hip - poly and locking ring were broken - cup and stem well fixed and retained.Doi: 1994.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
UNKNOWN HIP ACETABULAR LINERS
Type of Device
HIP ACETABULAR LINERS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key10422791
MDR Text Key203453237
Report Number1818910-2020-18345
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 08/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/18/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNK HIP ACETABULAR LINER
Was Device Available for Evaluation? No
Date Manufacturer Received08/25/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
(28 +5 COCR ARTICULEZE HEAD); (58/72 DURALOC LOCKING RING); (58/72 X 28 10 DEGREE DURALOC LINER)
Patient Outcome(s) Required Intervention;
Patient Age91 YR
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