MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TC3 RP TIBIAL INSERT S2.5,12.5; SIGMA REVISION IMPLANT : KNEE TIBIAL INSERT

Model Number	96-2332
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Muscular Rigidity (1968); Pain (1994)
Date of Event	06/21/2022
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
Revision of right revision total knee replacement.Pfc tc3 rp revision prosthesis insitu.Dr.Understood to have implanted the pfc tc3 rp prosthesis as a revision prosthesis.No knowledge or information regarding the original primary implant.No knowledge of any previous surgery dates or hospital where implanted.Attempts made to obtain this information without success.Revision for stiffness and pain.Proposal to convert to an srom hinge prosthesis by revising femoral component.This was attempted but the femoral prosthesis was unable to be explanted due to the significant degree of enhanced fixation.The bearing was eventually the only implant revised and removed.Doi: unknown.Dor: (b)(6) 2022.Right knee.
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 = a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.
Event or Problem Description
1.Are you able to provide the lot number of product 962332 (tc3 rp tibial insert s2.5,12.5)? no.2.Were there any allegations against any other of the components? unsure.3.Was there a surgical delay? if yes, how many minutes? not as such.

• Brand Name: TC3 RP TIBIAL INSERT S2.5,12.5
• Common Device Name: SIGMA REVISION IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY RAYNHAM, A DIV. OF DEPUY ORTHO 1219655; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14929680
• Report Number: 1818910-2022-12354
• Device Sequence Number: 19325304
• Product Code: NJL
• UDI-Device Identifier: 10603295242130
• UDI-Public: 10603295242130
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2022

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 Number: 96-2332
• Device Catalogue Number: 962332
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2022
• Supplement Date Received by Manufacturer: 07/21/2022
• Initial Report FDA Received Date: 07/06/2022
• Supplement Report FDA Received Date: 07/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MBT REVISION CEM TIB TRAY S2.5; TC3 RP TIBIAL INSERT S2.5,12.5; UNIVERSAL STEM 115X12MM FLUTED; UNIVERSAL STEM 75X10MM FLUTED; UNK KNEE FEMORAL ADAPTOR SIGMA; UNK KNEE FEMORAL SIGMA PS; UNK KNEE PATELLA SIGMA; UNKNOWN KNEE TIBIAL SLEEVE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female