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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 12.5; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
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DEPUY ORTHOPAEDICS INC US SIG RP AOX CRV INS SZ4 12.5; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT Back to Search Results
Model Number 1961-92-042
Medical Device Problem Code Unintended Movement (3026)
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 11/26/2020
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.Doi: (b)(6) 2020, 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.
 
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Brand Name
SIG RP AOX CRV INS SZ4 12.5
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 Key11123409
Report Number1818910-2021-00412
Device Sequence Number17113286
Product Code NJL
UDI-Device Identifier10603295076216
UDI-Public10603295076216
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 Number1961-92-042
Device Catalogue Number196192042
Device Lot Number9137536
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 Date01/06/2021
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; UNK KNEE TIBIAL INSERT SIGMA; 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; UNK KNEE TIBIAL INSERT SIGMA
Outcome Attributed to Adverse Event Required Intervention;
Patient Age59 YR
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