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

Model Number	6515.09.150
Medical Device Problem Codes	Unstable (1667); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	07/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Checking the manufacturing charts of the components involved in this event, no pre-existing anomalies were found in the (b)(4) items belonging to the lot number 21as0dj, nor in the (b)(4) items belonging to the lot number 19at20q.This is the first and only complaint received about these lot numbers.Neither x-rays nor explanted components were available to be shared with the manufacturer for further investigation.However, according to the information received by the complaint source, the patient is active and does golf; the surgeon reported no trauma to the knee experienced by this patient.The patient has a degenerative ankle problem that is failing and causing him to be misaligned in his extremity; this was causing him to be painful in his knee.Hence, considering that: - no pre-existing anomalies have been discovered by checking the manufacturing charts of the devices removed during the revision surgery hereby reported - based on the information received by the complaint source, the patient has a degenerative ankle problem that is causing him to be misaligned in his extremity and to be painful in his knee.We can conclude that the event is not product related.Pms data according to the available pms data, the revision rate of the physica ps femoral components belonging to the family product code 6515.09.Xxx, due to loosening, pain and instability, is lower than 0.01%.Based on the root cause analysis performed and according to the relevant pms data, no corrective action is required for this specific case.The manufacturer will continue monitoring the market to promptly detect any further similar issue.Note: this is a combined initial-final mdr.
Event or Problem Description
Knee revision surgery performed on (b)(6) 2025, due to instability and pain.The patient was having pain and instability in right knee.The femoral component was found loose.The following components were removed and replaced by physica ps pro components, and the liner was replaced by a hps stabilized insert: - physica ps femur comp.Right # 5 (part code 6515.09.150, lot number 21as0dj, sterilization (b)(6)) - physica ps tibial liner #5 (part code 6535.50.511, lot number 19at20q, sterilization (b)(6)).Instead, the tibial components and the patella were not revised: - physica fixed tibial plate # 5 (part code 6522.15.050, lot number 2023419, sterilization (b)(6)).- patellar prosthes.D.35 h.8.5mm (part code 6595.54.035, lot number 2110570, sterilization (b)(6)).- physica tibial stem l.20mm (part code 6590.15.020, lot number 2201601, sterilization (b)(6)).Previous surgery was performed on (b)(6) 2022.The patient is a male, date of birth (b)(6) 1952.The event happened in the united states.

• 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
• Manufacturer Contact: via nazionale 52; villanova di san daniele, udine 33038
• MDR Report Key: 22873367
• Report Number: 3008021110-2025-00108
• Device Sequence Number: 5688059
• 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
• Device Implanted Year: 2022
• 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): 08/22/2025

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: 6515.09.150
• Device Lot Number: 21AS0DJ
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/22/2025
• 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