MAUDE Adverse Event Report: LIMACORPORATE S.P.A PHYSICA; KR LINER LEFT #8 - H. 11

Model Number	6532.50.811
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	06/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery was performed on (b)(6) 2022 due to knee pain.Previous surgery was performed on (b)(6) 2018 and following components were implanted: - physica kr femur comp.Left #8 (part number 6511.09.580, lot 15as0ah, sterilization (b)(4)), - physica fixed tibial plate #8 (part number 6522.15.080, lot 1714230, sterilization (b)(4)), - physica kr tib.Liner left #8 (part number 6532.50.811, lot 15at1cb, sterilization (b)(4)).Patient had continuous pain in left knee.Patient had a manipulation that did not help and resulted in a knee revision, with explantation of above-mentioned original components and replacement with new knee system.Patient is male.The event occurred in the united states.
Additional Manufacturer Narrative
Review of manufacturing records did not highligh any pre-existing anomaly on involved batches that could have contributed to reported issue.The manufacturer will submit a final report as soon as the investigation is completed.

• Brand Name: PHYSICA
• Common Device Name: KR LINER LEFT #8 - H. 11
• 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: 24603381
• Report Number: 3008021110-2026-00143
• Device Sequence Number: 12858052
• Product Code: JWH
• UDI-Device Identifier: 08033390091060
• UDI-Public: 8033390091060
• Combination Product (Y/N): N
• PMA/510(K) Number: K141934
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/16/2026

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: 6532.50.811
• Device Lot Number: 15AT1CB
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/16/2026
• 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: Male