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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIG RP AOX CRV INS SZ4 15; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
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DEPUY ORTHOPAEDICS INC US SIG RP AOX CRV INS SZ4 15; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT Back to Search Results
Model Number 1961-92-043
Medical Device Problem Code Unintended Movement (3026)
Health Effect - Clinical Code Joint Laxity (4526)
Date of Event 12/16/2020
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 to address a spin-out of the poly.A replacement with a thicker poly was done on (b)(6) 2020.The surgeon wanted to put a more stable construct in.Doi: (b)(6) 2020, doi: (b)(6) 2020 (insert), dor: (b)(6) 2020, right knee.
 
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed h10 additional narrative: .
 
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Brand Name
SIG RP AOX CRV INS SZ4 15
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 Key11116791
Report Number1818910-2021-00168
Device Sequence Number3698921
Product Code NJL
UDI-Device Identifier10603295076223
UDI-Public10603295076223
Combination Product (Y/N)N
Initial Reporter StateMD
Initial Reporter CountryUS
PMA/510(K) Number
P830055
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2020
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,Followup
Report Date (Section B) 12/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model Number1961-92-043
Device Catalogue Number196192043
Device Lot Number8839000
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 12/16/2020
Supplement Date Received by Manufacturer01/28/2021
Initial Report FDA Received Date01/05/2021
Supplement Report FDA Received Date01/29/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
MBT CEM KEEL TIB TRAY SZ4; PFC*SIGMA/RD/DOME PAT 3PEG,35; SIG C/R POROCOAT FEM RT SZ 4; UNK CEMENT SMARTSET GMV; UNK CEMENT SMARTSET GMV
Outcome Attributed to Adverse Event Required Intervention;
Patient Age59 YR
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