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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TC3 RP TIBIAL INSERT S4,25.0; SIGMA REVISION IMPLANT : KNEE TIBIAL INSERT
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DEPUY ORTHOPAEDICS INC US TC3 RP TIBIAL INSERT S4,25.0; SIGMA REVISION IMPLANT : KNEE TIBIAL INSERT Back to Search Results
Model Number 96-2357
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Fall (1848); Pain (1994); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event 04/30/2021
Type of Reportable Event Serious Injury
Additional 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 or Problem Description
Clinical adverse event received for bone fracture of medial and lateral femoral condlyles: abnormal radiographic evaluation - likely femoral component loosening (unconfirmed), with fracture of the medial and lateral condyles, and instability event is serious and is considered severe event is definitely related to device and is definitely not related to procedure.Date of implantation: (b)(6) 2014.Date of revision: (b)(6) 2017 (all components) date of event (onset): (b)(6) 2021.(left knee).Treatment: revision of the femoral and insert components occurred on (b)(6) 2021.
 
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 product and lot code was provided, a manufacturing records evaluation (mre) was not performed.
 
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Brand Name
TC3 RP TIBIAL INSERT S4,25.0
Common Device Name
SIGMA REVISION IMPLANT : KNEE TIBIAL INSERT
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key12415376
Report Number1818910-2021-19226
Device Sequence Number3476403
Product Code NJL
UDI-Device Identifier10603295242444
UDI-Public10603295242444
Combination Product (Y/N)N
Initial Reporter StateCO
Initial Reporter CountryUS
PMA/510(K) Number
P830055
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source health professional,study
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 08/19/2021
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? No
Operator of Device Health Professional
Device Model Number96-2357
Device Catalogue Number962357
Device Lot NumberC48111
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 08/19/2021
Supplement Date Received by Manufacturer09/20/2021
Initial Report FDA Received Date09/02/2021
Supplement Report FDA Received Date09/22/2021
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
DEPUY CMW 3 40G; DEPUY CMW 3 40G; MBT REVISION CEM TIB TRAY SZ 5; MBT TRAY SLEEVE POR M/L 61MM; PFC SIGMA FEM POST AUG SZ4 4MM; PFC SIGMA FEM POST AUG SZ4 8MM; PFC*SIGMA TC3 FEM LEFT SZ4; PFC*SIGMA/OV/DOME PAT 3PEG,41; SIG FEM ADAP +2/-2 OFFSET BOLT; SIGMA FEM ADAPTER 5 DEGREE; TC3 RP TIBIAL INSERT S4,25.0; UNIVERSAL FEM SLV DIS POR 40MM; DEPUY CMW 3 40G; DEPUY CMW 3 40G; MBT REVISION CEM TIB TRAY SZ 5; MBT TRAY SLEEVE POR M/L 61MM; PFC SIGMA FEM POST AUG SZ4 4MM; PFC SIGMA FEM POST AUG SZ4 8MM; PFC*SIGMA TC3 FEM LEFT SZ4; PFC*SIGMA/OV/DOME PAT 3PEG,41; SIG FEM ADAP +2/-2 OFFSET BOLT; SIGMA FEM ADAPTER 5 DEGREE; TC3 RP TIBIAL INSERT S4,25.0; UNIVERSAL FEM SLV DIS POR 40MM
Outcome Attributed to Adverse Event Required Intervention;
Patient Age71 YR
Patient Weight100
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