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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK KNEE TIBIAL TRAY SIGMA
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DEPUY ORTHOPAEDICS INC US UNK KNEE TIBIAL TRAY SIGMA Back to Search Results
Catalog Number UNK KNEE TIBIAL TRAY SIGMA
Device Problem Difficult to Insert (1316)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/08/2021
Event Type  malfunction  
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
Patient was revised due to tibial insert wouldn't seat in the tibial tray.Doi: unknown, dor: (b)(6) 2021, left knee.
 
Manufacturer Narrative
Product complaint (b)(4).Investigation summary: the device associated with this report was not returned for evaluation.The investigation could not draw any conclusions about the reported event without the device to examine.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: lot information not available.Corrected: b1 (adverse event), b2 (required intervention).B1 (adverse event).And b2 (required intervention).Should not have been checked, as there was no patient consequences that was reported.
 
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Brand Name
UNK KNEE TIBIAL TRAY SIGMA
Type of Device
KNEE TIBIAL TRAY
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key12063785
MDR Text Key258627757
Report Number1818910-2021-13553
Device Sequence Number1
Product Code HRY
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 06/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue NumberUNK KNEE TIBIAL TRAY SIGMA
Was Device Available for Evaluation? No
Date Manufacturer Received08/06/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
SIGMA HP UNI INS SZ2 7MM LM/RL
Patient Outcome(s) Required Intervention;
Patient Age64 YR
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