MAUDE Adverse Event Report: Limacorporate S.p.A PHYSICA KR; PHYSICA KR (cross-linked UHMWPE with Vitamin E) - Tibial Liner #4 H. 11 mm Right

Model Number	6531.54.411
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	12/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No pre-existing anomaly was detected by checking the manufacturing charts of the lot number.We will submit a final report as soon as the investigation is complete.
Event or Problem Description
Knee revision surgery performed on (b)(6) 2024, due to instability.The following liner was removed: physica kr tib.Liner right #4 (part number 6531.54.411, lot number 2106267, sterilization (b)(4) and replaced by physica kr liner (part code 6531.54.416, lot number 2100772, sterilization (b)(4).Previous surgery took place on (b)(6) 2022.The patient is a female, date of birth may (b)(6) 1946.The event happened in the united states.

• Brand Name: PHYSICA KR
• Common Device Name: PHYSICA KR (cross-linked UHMWPE with Vitamin E) - Tibial Liner #4 H. 11 mm Right
• 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: 21362126
• Report Number: 3008021110-2025-00004
• Device Sequence Number: 20941247
• Product Code: MBH
• UDI-Device Identifier: 08033390182287
• UDI-Public: 08033390182287
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K201084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2026

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: 6531.54.411
• Device Lot Number: 2106267
• 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: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/12/2025
• Supplement Report FDA Received Date: 08/04/2026
• 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: Unknown