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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK KNEE TIBIAL TRAY UNI
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DEPUY ORTHOPAEDICS INC US UNK KNEE TIBIAL TRAY UNI Back to Search Results
Catalog Number UNK KNEE TIBIAL TRAY UNI
Device Problem Difficult to Insert (1316)
Patient Problems Not Applicable (3189); No Code Available (3191)
Event Date 09/25/2020
Event Type  malfunction  
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 sigma hp poly would not engage in the tibial tray.Seems to have a deformed lip on the insert there was a surgical delay of 10 minutes.
 
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 device history record (dhr) review, was not possible because the required lot number was not provided.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.
 
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Brand Name
UNK KNEE TIBIAL TRAY UNI
Type of Device
KNEE TIBIAL TRAY
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key10672131
MDR Text Key212553457
Report Number1818910-2020-22201
Device Sequence Number1
Product Code JWH
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 09/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNK KNEE TIBIAL TRAY UNI
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 09/25/2020
Initial Date FDA Received10/13/2020
Supplement Dates Manufacturer Received11/19/2020
Supplement Dates FDA Received11/20/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
SIGMA HP UNI INS SZ5 11 MM LMRL
Patient Age64 YR
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