MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TC3 RP TIBIAL INSERT S3,12.5; SIGMA REVISION IMPLANT : KNEE TIBIAL INSERT

Model Number	96-2342
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The tc3 total knee prosthesis has been "unbundled" (see photos in attachment).It was decided to pose a noiles, taking into account the number of interventions already underwent by the patient without changing the tibia.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the device associated with this report was returned to depuy synthes for evaluation, additionally x-rays were provided for evaluation.The photo investigation and visual examination found damage on the middle post on the top of the device.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TC3 RP TIBIAL INSERT S3,12.5
• 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 ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 17105824
• Report Number: 1818910-2023-12030
• Device Sequence Number: 19541615
• Product Code: NJL
• UDI-Device Identifier: 10603295242222
• UDI-Public: 10603295242222
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• 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): 06/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: 96-2342
• Device Catalogue Number: 962342
• Device Lot Number: J31T97
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2023
• Supplement Date Received by Manufacturer: 06/15/2023
• Initial Report FDA Received Date: 06/12/2023
• Supplement Report FDA Received Date: 06/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MBT REVISION CEM TIB TRAY SZ 3; P.F.C.* FLUT TIB ROD 75X12MM; P.F.C.* FLUT TIB ROD 75X18MM; PFC SIGMA FEM POST AUG SZ3 4MM; PFC*SIGMA DIS AUG 4MM,SZ3,LEFT; PFC*SIGMA TC3 FEM LEFT SZ3; SIGMA FEM ADAPTER 7 DEGREE; SIGMA FEM ADAPTER NEUTRAL BOLT; UNIV FEM SLEEVE CEM 20MM; UNIV FEM SLEEVE CEM 20MM; UNKNOWN KNEE FEMORAL ADAPTOR
• Patient Sex: Unknown