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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA STAB GVF INS 5 8MM; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
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DEPUY ORTHOPAEDICS INC US SIGMA STAB GVF INS 5 8MM; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT Back to Search Results
Model Number 1581-25-008
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Joint Laxity (4526)
Date of Event 09/30/2021
Type of Reportable Event Serious Injury
Additional 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 or Problem Description
The patient was revised due to instability.The surgeon increased poly thickness from 8mm to 12.5mm and was happy with knee stability.There were no deficiencies noted with the product and no delay in procedure.Lot number was not legible and poly will not be available for return since it was disposed of by hospital.Doi: unknown - dor: (b)(6) 2021 (left knee).
 
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Brand Name
SIGMA STAB GVF INS 5 8MM
Common Device Name
SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key12617549
Report Number1818910-2021-22623
Device Sequence Number3725788
Product Code JWH
UDI-Device Identifier10603295064572
UDI-Public10603295064572
Combination Product (Y/N)N
Initial Reporter StateAK
Initial Reporter CountryUS
PMA/510(K) Number
K033272
Number of Events Summarized1
Summary Report (Y/N)N
Device Explanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 09/30/2021
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
Operator of Device Health Professional
Device Model Number1581-25-008
Device Catalogue Number158125008
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/30/2021
Initial Report FDA Received Date10/12/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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