MAUDE Adverse Event Report: LIMACORPORATE S.P.A. PHYSICA TT; PHYSICA TT - TI6AL4V EBM - FIXED TIBIAL PLATE #7 UNCEMENTED

Model Number	6521.14.070
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation: checking the manufacturing charts of the component with lot number 2212388, no pre-existing anomaly was discovered on the (b)(4) items belonging to this lot number.The manufacturer will submit a final mdr as soon as the investigation is complete.
Event or Problem Description
Revision surgery on (b)(6) 2025, due to failed porous lima tibial component: tibia collapsed and needed full revision.The following components were revised:z - physica ps - femoral peg (part code 6515.09.900, lot number 2322178, sterilization 2300215).- ps femoral component #8 right (part code 6515.10.180, lot number 2316633, sterilization 2300195).- physica tt fix.Tibial tray #7 (part code 6521.14.070, lot number 2212388, sterilization 2200277).- physica ps tibial liner #7 (part code 6535.50.710 , lot number 22bc06j, sterilization 2200263).- patellar prosthes.D.38 h.10mm (part code 6595.54.038, lot number 22at1v6, sterilization 2300228).The removed devices were replaced by third-party components.Surgery was completed as intended.Previous surgery was performed on (b)(6) 2023.The patient is a male, date of birth (b)(6) 1951.The event happened in the united states.

• Brand Name: PHYSICA TT
• Common Device Name: PHYSICA TT - TI6AL4V EBM - FIXED TIBIAL PLATE #7 UNCEMENTED
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer Contact: via nazionale 52; villanova di san daniele, 33038
• MDR Report Key: 21966608
• Report Number: 3008021110-2025-00046
• Device Sequence Number: 15481700
• Product Code: MBH
• UDI-Device Identifier: 08033390174305
• UDI-Public: 08033390174305
• Combination Product (Y/N): N
• PMA/510(K) Number: K201084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/06/2025

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
• Device Model Number: 6521.14.070
• Device Lot Number: 2212388
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/06/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown