MAUDE Adverse Event Report: LIMACORPORATE S.P.A. PHYSICA; FIXED TIBIAL PLATE

Model Number	6522.15.050
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/04/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
By the check of the device history records, no pre-existing anomaly was detected on the devices released with the lot n.Involved.This is the first and only complaint recorded on this lot n.(2200885).A final report will be submitted after the investigation.
Event or Problem Description
Knee revision surgery due to aseptic mobilization, performed on (b)(6) 2026.The previous surgery was carried out in 2022.Patient is female, 75 years old.This event occurred in italy.

• Brand Name: PHYSICA
• Common Device Name: FIXED TIBIAL PLATE
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale, 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 25094526
• Report Number: 3008021110-2026-00213
• Device Sequence Number: 4968367
• Product Code: JWH
• UDI-Device Identifier: 08033390089920
• UDI-Public: 08033390089920
• Combination Product (Y/N): N
• PMA/510(K) Number: K141934
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: 6522.15.050
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/06/2026
• 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