MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC*SIGMA TC3 FEM LEFT SZ3; SIGMA REVISION IMPLANT : KNEE FEMORAL

Model Number	96-0082
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Pain (1994); Limb Fracture (4518)
Date of Event	02/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The tc3 total knee prosthesis has been "unbundled." 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).The device catalog number is unknown; therefore, udi is unavailable.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.
Event or Problem Description
Additional information was received and stated the following: spontaneous pain in the left knee, hemartosis, no trauma.The patient was operated on (b)(6) 2019 for revision arthroplasty of the knee.Radiological diagnosis: femoral implant rupture at the casing/femoral sleeve junction.Periprosthetic fracture.Arthroplasty change.Revision isolated on the femoral side - hinge prosthesis implantation date: (b)(6) 2019.Date of incident: (b)(6) 2023.
Additional Manufacturer Narrative
Product complaint (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: d4 (lot), d9, d10.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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 nothing indicative of a device nonconformance, however some extraction marks can be observed.The reported allegation cannot be confirmed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : a device history record (dhr) review or manufacturing records evaluation (mre) was not possible because the investigation was not able to retrieve a valid required lot code.

• Common Device Name: SIGMA REVISION IMPLANT : KNEE FEMORAL
• 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 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 16706331
• Report Number: 1818910-2023-07524
• Device Sequence Number: 14882898
• Product Code: JWH
• UDI-Device Identifier: 10603295232490
• UDI-Public: 10603295232490
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K952830
• 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,Followup,Followup,Followup
• Report Date (Section B): 04/10/2023

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: 96-0082
• Device Catalogue Number: 960082
• Device Lot Number: F5H6C-3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2023
• Supplement Date Received by Manufacturer: 04/13/2023; 05/05/2023; 06/09/2023; 06/15/2023
• Initial Report FDA Received Date: 04/10/2023
• Supplement Report FDA Received Date: 04/19/2023; 05/09/2023; 06/11/2023; 06/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 SZ 3.; MBT REVISION CEM TIB TRAY SZ 3.; MBT TRAY SLEEVE POR M/L 37MM.; MBT TRAY SLEEVE POR M/L 37MM.; P.F.C.* FLUT TIB ROD 75X12MM.; P.F.C.* FLUT TIB ROD 75X12MM.; P.F.C.* FLUT TIB ROD 75X18MM.; P.F.C.* FLUT TIB ROD 75X18MM.; PFC SIGMA FEM POST AUG SZ3 4MM.; PFC SIGMA FEM POST AUG SZ3 4MM.; PFC*SIGMA DIS AUG 4MM,SZ3,LEFT.; PFC*SIGMA DIS AUG 4MM,SZ3,LEFT.; PFC*SIGMA TC3 FEM LEFT SZ3.; PFC*SIGMA TC3 FEM LEFT SZ3.; SIGMA FEM ADAPTER 7 DEGREE.; SIGMA FEM ADAPTER NEUTRAL BOLT.; SIGMA FEM ADAPTER NEUTRAL BOLT.; TC3 RP TIBIAL INSERT S3,12.5.; TC3 RP TIBIAL INSERT S3,12.5.; UNIV FEM SLEEVE CEM 20MM.; UNIV FEM SLEEVE CEM 20MM.; UNIV FEM SLEEVE CEM 20MM.; UNKNOWN KNEE FEMORAL ADAPTOR.; UNKNOWN KNEE FEMORAL ADAPTOR.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown