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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 Device Dislodged or Dislocated (2923)
Patient Problems Joint Dislocation (2374); Unspecified Tissue Injury (4559)
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 dislocation.Cup, liner removed and replaced with constrained liner.No surgical delay.Cup was not loose.Liner was not loose.Soft tissue issue so liner was removed and a constrained liner was implanted in existing cup.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.The information received will be retained for potential series investigations if triggered by trend analysis or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Device history lot : a device history record (dhr) review, was not possible because the required lot code(s) was not provided.
 
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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 Key10984512
MDR Text Key220700427
Report Number1818910-2020-26715
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 11/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/10/2020
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 Received01/11/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
DLT TS CER HD 12/14 36MM +5.0; UNKNOWN HIP ACETABULAR CUP; DLT TS CER HD 12/14 36MM +5.0; UNKNOWN HIP ACETABULAR CUP
Patient Outcome(s) Required Intervention;
Patient Age68 YR
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