MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TC3 RP TIBIAL INSERT S4,10.0; SIGMA REVISION IMPLANT : KNEE TIBIAL INSERT

Model Number	96-2351
Medical Device Problem Codes	Fracture (1260); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); Joint Laxity (4526)
Date of Event	08/27/2021
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
Disjointment of knee prothesis and rupture of the pe insert.Revision surgery was needed.Doi: unknown.Dor: (b)(6) 2021, unknown side.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.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 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).A manufacturing records evaluation (mre) was not performed.

• Brand Name: TC3 RP TIBIAL INSERT S4,10.0
• 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 Key: 12554004
• Report Number: 1818910-2021-21528
• Device Sequence Number: 19853645
• Product Code: NJL
• UDI-Device Identifier: 10603295242345
• UDI-Public: 10603295242345
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 96-2351
• Device Catalogue Number: 962351
• Device Lot Number: J19Z26
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/13/2021
• Supplement Date Received by Manufacturer: 10/12/2021
• Initial Report FDA Received Date: 09/30/2021
• Supplement Report FDA Received Date: 10/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MBT REVISION CEM TIB TRAY SZ 3; SIGMA FEM ADAPTER NEUTRAL BOLT; TC3 RP TIBIAL INSERT S4,10.0; UNIVERSAL FEM SLV DIS POR 46MM; UNIVERSAL STEM 75X20MM FLUTED; UNKNOWN KNEE FEMORAL; UNKNOWN KNEE FEMORAL ADAPTOR; MBT REVISION CEM TIB TRAY SZ 3; SIGMA FEM ADAPTER NEUTRAL BOLT; TC3 RP TIBIAL INSERT S4,10.0; UNIVERSAL FEM SLV DIS POR 46MM; UNIVERSAL STEM 75X20MM FLUTED; UNKNOWN KNEE FEMORAL; UNKNOWN KNEE FEMORAL ADAPTOR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR