MAUDE Adverse Event Report: LIMACORPORATE S.P.A. PHYSICA PS; PS FEMORAL COMPONENTS RIGHT #5

Model Number	6515.09.150
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	07/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery of right knee prosthesis due to septic mobilization.Revision surgery date is (b)(6) 2026, and the previous surgery date is (b)(6) 2026.The components involved are the following: - physica ps femur comp.Right #5 code 651509150 lot 25as03r, ster.(b)(4).- physica fixed tibial plate #6 code 652215060 lot 2431675, ster.(b)(4).- physica ps tibial liner #6 code 653550611 lot 24at1yg, ster.(b)(4).- physica patella prosth.D.32mm code 659550032 lot 24at6aw, ster.(b)(4).- physica ps - femoral peg code 651509900 lot 2506016, ster.(b)(4).The patient is male, 67 years old.This event occurred in italy.
Additional Manufacturer Narrative
No pre-existing anomalies were detected by the check of the sterilization charts of the lot numbers involved.A final report will be submitted upon completion of the investigation.

• Brand Name: PHYSICA PS
• Common Device Name: PS FEMORAL COMPONENTS RIGHT #5
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale, 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 25903388
• Report Number: 3008021110-2026-00289
• Device Sequence Number: 5791328
• Product Code: JWH
• UDI-Device Identifier: 08033390095532
• UDI-Public: 08033390095532
• Combination Product (Y/N): N
• PMA/510(K) Number: K152008
• 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
• Report Date (Section B): 07/22/2026

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: 6515.09.150
• Device Lot Number: 25AS03R
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/22/2026
• 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