MAUDE Adverse Event Report: LIMACORPORATE S.P.A PHYSICA; KR LINER RIGHT #7 - H. 14

Model Number	6531.50.714
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	04/06/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of manufacturing and sterilization records did not highlifht any pre-existing anomaly or non conformity that could have contributed to reported 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) 2022 to restore knee functionality after removal of tibial liner.Original surgery occurred on (b)(6) 2018 to implant physica kr knee system consisting of following components: - physica kr femur comp.Right #8 (part number 6511.09.180, lot 16as039, sterilization (b)(4)), - physica fixed tibial plate #7 (part number 6522.15.070, lot 1801260, sterilization (b)(4)), - physica kr tib.Liner right #7 (part number 6531.50.714, lot 14l0090, sterilization (b)(4)).Patient started to have bursitis, and at a follow-up appointment stated she was falling because of her knee and continued pain.Initially she tried physical therapy and a knee brace but continued to have falls and pain.X-ray scan did not show loosening according to medical team.Above mentioned liner was explanted on (b)(6) 2021.Patient is female.The event occurred in the united states.

• Brand Name: PHYSICA
• Common Device Name: KR LINER RIGHT #7 - H. 14
• 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: 24603382
• Report Number: 3008021110-2026-00142
• Device Sequence Number: 20928794
• Product Code: JWH
• UDI-Device Identifier: 08033390088954
• UDI-Public: 8033390088954
• 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: 6531.50.714
• Device Lot Number: 14L0090
• 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