MAUDE Adverse Event Report: Limacorporate S.p.A. PHYSICA; Tibial Plate #9

Model Number	Fixed Tibial Plate
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	04/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The complaint source reported that revision surgery was performed on (b)(6) 2025 due to a periprosthetic infection in the right knee.Previous surgery performed on (b)(6) 2022.The following devices were explanted: · physica ps femur comp.Right #8 (product code: 6515.09.180, lot: 17as0t7 - ster.2100167) - sold in us · physica fixed tibial plate #9 (product code: 6522.15.090, lot: 2101104 - ster.2100091)- sold in us · physica ps tibial liner #9 (product code: 6535.50.910, lot: 21at19t - ster.2100357) - sold in us · physica tibial stem l.20mm (product code: 6590.15.020, lot: 2201697 - ster.220009) - sold in us patient: male, 55 years old.Event occurred in italy.
Additional Manufacturer Narrative
According to the sterilization charts no pre-existing anomalies were detected on the lot numbers involved.A final report will be provided when the investigation is completed.
Event or Problem Description
The complaint source reported that revision surgery was performed on (b)(6) 2025 due to a periprosthetic infection in the right knee.Previous surgery performed on (b)(6) 2022.The following devices were explanted: · physica ps femur comp.Right #8 (product code: 6515.09.180, lot: 17as0t7 - ster.2100167) - sold in us.· physica fixed tibial plate #9 (product code: 6522.15.090, lot: 2101104 - ster.2100091)- sold in us.· physica ps tibial liner #9 (product code: 6535.50.910, lot: 21at19t - ster.2100357) - sold in us.· physica tibial stem l.20mm (product code: 6590.15.020, lot: 2201697 - ster.220009) - sold in us.Patient: male, 55 years old.Event occurred in italy.
Additional Manufacturer Narrative
According to the sterilization charts no pre-existing anomalies were detected on the lot numbers involved.The available pre-revision radiographs and explant photographs were reviewed by a medical expert, who considered a low-grade prosthetic joint infection (pji) to be a possible contributing factor to the revision.Radiographs showed osteolysis beneath the femoral component and loosening of the tibial component, findings considered consistent with infection-related failure.In conclusion, the exact root cause of the event could not be determined.However, based on the following: - review of the sterilization records for the involved lot numbers did not identify any pre-existing anomalies.- the medical expert evaluation identified a low-grade prosthetic joint infection (pji) as a possible contributing factor the event is considered not to be product related.Pms data: according to pms data of limacoporate the revision rate of physica ps prothesis due to revision is nearly 0.01%.No corrective action needed following this complaint.The company will continue monitoring the market to promptly detect any further similar event.This is a final mdr report.

• Brand Name: PHYSICA
• Common Device Name: Tibial Plate #9
• Manufacturer (Section D): Limacorporate S.p.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer Contact: via nazionale 52; villanova; san daniele del friuli, udine 30038
• MDR Report Key: 22008375
• Report Number: 3008021110-2025-00060
• Device Sequence Number: 5343540
• Product Code: JWH
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K141934
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2026

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: Fixed Tibial Plate
• Device Catalogue Number: 6522.15.090
• Device Lot Number: 2101104
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2025
• Supplement Date Received by Manufacturer: 04/29/2025
• Initial Report FDA Received Date: 05/13/2025
• Supplement Report FDA Received Date: 09/11/2026
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown