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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK HIP BONE SCREW
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DEPUY ORTHOPAEDICS INC US UNK HIP BONE SCREW Back to Search Results
Catalog Number UNK HIP BONE SCREW
Device Problem Osseointegration Problem (3003)
Patient Problems Inadequate Osseointegration (2646); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 12/02/2020
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 loosening of the duraloc cup at bone to implant interface.Cup was loose and completely vertical so surgeon removed cup and replaced with a custom triflange due to bone loss on the acetabulum.No delay in surgery reported.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
UNK HIP BONE SCREW
Type of Device
BONE SCREW
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key11024683
MDR Text Key221999832
Report Number1818910-2020-27120
Device Sequence Number1
Product Code HWC
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 12/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNK HIP BONE SCREW
Was Device Available for Evaluation? No
Date Manufacturer Received01/14/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
25MM X6.5MM SCREWS; 25MM X6.5MM SCREWS; 28+8.5 UK HEAD 12/14 TAPER; 30MM X 6.5MM SCREWS; DURALOC 1200 SERIES 72MM OD; ENDURON 10D 60 OR 72ODX28ID; 25MM X6.5MM SCREWS; 25MM X6.5MM SCREWS; 28+8.5 UK HEAD 12/14 TAPER; 30MM X 6.5MM SCREWS; DURALOC 1200 SERIES 72MM OD; ENDURON 10D 60 OR 72ODX28ID
Patient Outcome(s) Required Intervention;
Patient Age57 YR
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