MAUDE Adverse Event Report: LIMACORPORATE S.P.A PHYSICA; PHYSICA LMC LINERS (CROSS-LINKED UHMWPE WITH VITAMIN E) - LEFT #8 - H. 11

Model Number	6537.54.811
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	03/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery was performed on (b)(6) 2026 due to infection.During revision the pre-existing lmc tibial liner #8 h11 left (part number 6537.54.811, lot 2103066, sterilization (b)(6)) was removed a replaced with a new one.Also, a washout procedure was performed to clean the infected area and promote healing.Surgery was completed as intended.Previous surgery is unknown.Patient is male, date of birth (b)(6) 1954.The event occurred in the united states.
Additional Manufacturer Narrative
Review of manufacturing and sterilization records did not hihglight any pre-existing anomaly that could have contributed to reported issue.From follow-up communication with complaint source, the explanted component was in perfect conditions but no x-rays, lab analysis report or patient clinical history could be shared to further investigate.Review of complaint database did not identify any further complaint on the involved batch and sterilization numbers, thus excluding a systematic quality issue.Based on the available pms data, no concerning trend has been identified and the revision rate of lmc tibial liners, belonging to the family product codes 6536/6537.Xx.Xxx, due to infection is around (b)(4).Taking into account that no further information is available to establish the specific root cause, but no deviation in sterilization records nor other complaints on the same sterilization lot were identified, the manufacturer has no evidence to consider the event as product related.According to the investigation carried out, no corrective action is needed for this event.The manufacturer will continue monitoring the market in order to detect any similar event.

• Brand Name: PHYSICA
• Common Device Name: PHYSICA LMC LINERS (CROSS-LINKED UHMWPE WITH VITAMIN E) - 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: 25067090
• Report Number: 3008021110-2026-00194
• Device Sequence Number: 10357579
• Product Code: MBH
• UDI-Device Identifier: 08033390189811
• UDI-Public: 8033390189811
• Combination Product (Y/N): N
• PMA/510(K) Number: K201084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• 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): 05/04/2026

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: 6537.54.811
• Device Lot Number: 2103066
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/04/2026
• 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 Age: 71 YR
• Patient Sex: Male