MAUDE Adverse Event Report: LIMACORPORATE S.P.A. HYSICA LMC; PHYSICA LMC (CROSS-LINKED UHMWPE WITH VITAMIN E) - TIBIAL LINER # 5 H. 12 MM RIG

Catalog Number	6536.54.512
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The check of dhrs of the involved lot number did not highlight any pre-existing anomalies of the pieces manufactured with lot number 2023827.This is the first complaint received on the lot number.A final report will be submitted after the investigation.
Event or Problem Description
On (b)(6) 2025 during a knee surgery there were issues inserting an lmc tibial liner #5 h12 right - limavit (product code: 6536.54.512, lot: 2023827 - ster: (b)(4).A new device with the same product code and lot number was opened, but also in this second case the device did not insert definitively.In both cases the insert did not fit and remained raised 1mm.To conclude the procedure another, insert physica cr tibial liner (product code: 6533.50.512, lot: 23at3n8 - ster.(b)(4) was implanted and this fit without any problem.The surgery was prolonged by nearly 6/7 minutes.Event occurred in italy.

• Brand Name: HYSICA LMC
• Common Device Name: PHYSICA LMC (CROSS-LINKED UHMWPE WITH VITAMIN E) - TIBIAL LINER # 5 H. 12 MM RIG
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer Contact: via nazionale 52; villanova; san daniele del friuli - udine, 33038
• MDR Report Key: 22319936
• Report Number: 3008021110-2025-00094
• Device Sequence Number: 18350484
• Product Code: HRY
• UDI-Device Identifier: 08033390188739
• UDI-Public: 08033390188739
• Combination Product (Y/N): N
• PMA/510(K) Number: K201084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 06/23/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 6536.54.512
• Device Lot Number: 2023827
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2025
• Initial Report FDA Received Date: 06/24/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown