MAUDE Adverse Event Report: LIMACORPORATE S.P.A PHYSICA PS; PS LINER #3 - H. 11

Model Number	6535.50.311
Medical Device Problem Codes	Difficult to Insert (1316); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During the tka surgical procedure performed on (b)(6) 2025, a trial liner of 11 mm was initially selected and tested.Based on the intraoperative assessment, the surgeon decided to proceed with the definitive 11 mm liner.Upon attempting to insert the definitive 11 mm liner into the tibial tray, it was not possible to achieve proper seating of the component.The surgeon conducted a visual inspection to check for any residual cement fragments or other obstructions on the tray surface, but none were identified.Despite this, multiple attempts were made, all of which were unsuccessful.Following these repeated attempts, the surgeon suspected a possible deformation in the posterior part of the liner.A new definitive liner of 12 mm was then opened and insertion was attempted; however, this liner also could not be inserted into the tibial tray.The surgical procedure was carried out in accordance with the recommended surgical technique for the physica ps system.Ultimately, in order to complete the surgery, the liner was inserted with the application of force.As a result of this issue, the overall surgical time was prolonged by approximately 30 minutes.Below is the suspected product: · physica ps tibial liner #3 (product code 6535.50.311, lot #16at1lz) - product sold in us the patient is a 76 -year-old female.Event happened in japan.
Additional Manufacturer Narrative
Investigation checking the manufacturing charts of the involved lot # 16at1lz, no pre-existing anomaly was found on the 54 devices manufactured with the same lot #.This is the first and only complaint received on this lot #.We submit a final mdr when the investigation is complete.

• Brand Name: PHYSICA PS
• Common Device Name: PS LINER #3 - 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: 22506240
• Report Number: 3008021110-2025-00090
• Device Sequence Number: 21148509
• Product Code: JWH
• UDI-Device Identifier: 08033390095822
• UDI-Public: 08033390095822
• Combination Product (Y/N): N
• PMA/510(K) Number: K152008
• 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,Followup
• Report Date (Section B): 07/11/2025

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 Model Number: 6535.50.311
• Device Catalogue Number: 6535.50.311
• Device Lot Number: 16AT1LZ
• Is the Reporter a Health Professional?: 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: 07/15/2025
• Supplement Report FDA Received Date: 06/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Other
• Patient Sex: Unknown