MAUDE Adverse Event Report: LIMACORPORATE S.P.A. PHYSICA KR; PHYSICA KR (CROSS-LINKED UHMWPE WITH VITAMIN E) - TIBIAL LINER #7 H. 10 MM RIGHT

Model Number	6531.54.710
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	07/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Knee revision surgery, performed on (b)(6) 2025, due to infection.The following component was removed: physica kr tib.Liner right #7 (part code 6531.54.710, lot number 2110652, sterilization (b)(4).And replaced with the following new one: physica kr tib.Liner right #7 (part code 6531.54.710, lot number 2021282, sterilization (b)(4).The other components previously implanted were left in situ: physica kr femur comp.Right #8 (part code 6511.09.180, lot number 19as0k9, sterilization (b)(4).Physica fixed tibial plate #7 (part code 6522.15.070, lot number 2221171, sterilization (b)(4).Patellar prosthes.D.32 h.8.5mm (part code 6595.54.032, lot number 2021985, sterilization (b)(4).Previous surgery performed on (b)(6) 2023.The patient is a male, date of birth (b)(6) 1954.The event happened in the united states.
Additional Manufacturer Narrative
Investigation checking the manufacturing and sterilization charts, no pre-existing anomaly was found in the 36 items belonging to the lot number 2110652 and sterilization (b)(4).This is the first and only complaint received regarding this lot number.We did not receive any additional information on this event, except for the information reported in the event description.Hence, taking into account that: no pre-existing anomalies were found by checking the manufacturing and sterilization charts of the involved lot number.We have no evidence to consider the event as product related.Pms data based on the available pms data, the revision rate of physica kr tib.Liners, belonging to the family product codes 6531.50.Xxx - 6532.50.Xxx - 6531.54.Xxx - 6532.54.Xxx due to infection is lower than 0.01%.Based on the root cause analysis performed and according to the relevant pms data, no corrective action is required for this specific case.The manufacturer will continue monitoring the market to promptly detect any further similar issue.Note: this is a combined initial-final mdr.

• Brand Name: PHYSICA KR
• Common Device Name: PHYSICA KR (CROSS-LINKED UHMWPE WITH VITAMIN E) - TIBIAL LINER #7 H. 10 MM RIGHT
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer (Section G): 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: 22861640
• Report Number: 3008021110-2025-00105
• Device Sequence Number: 21146755
• Product Code: MBH
• UDI-Device Identifier: 08033390182690
• UDI-Public: 08033390182690
• Combination Product (Y/N): N
• PMA/510(K) Number: K201084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/21/2025

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: 6531.54.710
• Device Lot Number: 2110652
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/21/2025
• 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