MAUDE Adverse Event Report: LIMACORPORATE S.P.A PHYSICA; KR LINER LEFT #5 - H. 10

Model Number	6532.50.510
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Implant Pain (4561)
Date of Event	08/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of manufacturing and sterilization records for explanted components did not highlight any pre-existing anomaly or non-conformity that could have contributed to the issue.The manufacturer will provide a final report as soon as the investigation is completed.
Event or Problem Description
Revision surgery was performed on (b)(6) 2021 due to loss of range of motion and continual pain due to scar tissue.Symptoms were reported by patient during annual follow-up.Original surgery was performed on (b)(6) 2018 to implant following knee prosthetic components: physica fixed tibial plate #5 (part number 6522.15.050, lot 1712528, sterilization (b)(4), physica kr tib.Liner left #5 (part number 6532.50.510, lot 15at0vb, sterilization (b)(4), physica kr femur comp.Left #6 (part number 6511.09.560, lot 17as0fy, sterilization (b)(4), physica patella prosth.D.35mm (part number 6595.50.035, lot 17at0ds, sterilization (b)(4).Components were originally explanted on (b)(6) 2021 and around one month later new physica kr components were implanted to restore knee functionality.Surgery was completed as intended.Patient is female.The event occurred in the united states.

• Brand Name: PHYSICA
• Common Device Name: KR LINER LEFT #5 - H. 10
• 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: 24603379
• Report Number: 3008021110-2026-00141
• Device Sequence Number: 20928793
• Product Code: JWH
• UDI-Device Identifier: 08033390089395
• UDI-Public: 8033390089395
• 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: 2021
• 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: 6532.50.510
• Device Lot Number: 15AT0VB
• 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: Female