MAUDE Adverse Event Report: LIMACORPORATE S.P.A. PHYSICA TT; PHYSICA TT - TI6AL4V EBM - FIXED TIBIAL PLATE #5 UNCEMENTED

Model Number	6521.14.050
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	12/04/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The check of dhrs of the involved lot number 2211436 did not highlight any pre-existing anomalies on the items manufactured with this lot number.This is the first and only complaint received on this lot number.A final report will be submitted after the investigation is completed.
Event or Problem Description
On (b)(6) 2025 revision of knee prothesis due to sintering of physica tt fix.Tibial tray #5 (product code: 6521.14.050, lot: 2211436 - ster: (b)(4).During revision the total primary knee has been changed to a rotating hinged knee.Previous surgery was performed on (b)(6) 2023.During one year-control only minor radiologic signs of sintering showed up.Increasing sintering within the second year of post-op.Patient did not report any trauma.Product codes and lot numbers of the other devices implanted on the first surgery on 2023: physica tt fix.Tibial tray #5 (product code: 6521.14.050, lot: 2211436 - ster: (b)(4), ps femoral component #5 left (product code: 6515.10.550, lot: 2222424 - ster: (b)(4), physica ps tibial liner #5 (product code: 6535.50.511, lot: 22bc069 - ster: (b)(4), physica ps - femoral peg (product code: 6515.09.900, lot: 2313310 - ster: (b)(4).Patient: female, 75 years old, approximate height 1.65(m), approximate weight 58 (kg), active level, no smoking.Event occurred in austria.

• Brand Name: PHYSICA TT
• Common Device Name: PHYSICA TT - TI6AL4V EBM - FIXED TIBIAL PLATE #5 UNCEMENTED
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 25238766
• Report Number: 3008021110-2026-00227
• Device Sequence Number: 9724971
• Product Code: JWH
• UDI-Device Identifier: 08033390169912
• UDI-Public: 08033390169912
• Combination Product (Y/N): N
• 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): 05/19/2026

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: 6521.14.050
• Device Catalogue Number: 6521.14.050
• Device Lot Number: 2211436
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 05/21/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown