MAUDE Adverse Event Report: LIMACORPORATE S.P.A. PHYSICA; PATELLAR PROSTHESIS DIA. 35MM

Model Number	6595.50.035
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	04/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Knee revision surgery performed on (b)(6) 2025.The patella ripped through the soft tissue and caused it to be loose.The components involved in this event were the following: - physica kr tib.Liner left #8 (part code 6532.50.810, lot number 16at1l9, sterilization (b)(4)).- physica patella prosth.D.35mm (part code 6595.50.035, lot number 18at0ub, sterilization (b)(4)).During the revision surgery, the tibial liner was replaced by a physica lmc tib.Liner (part code 6537.54.810, lot 2124292, sterilization (b)(4)).Previous surgery took place on (b)(6) 2019.The patient is a male, date of birth (b)(6).The event happened in the united states.
Additional Manufacturer Narrative
Investigation: checking the manufacturing charts of the patella prostheses belonging to the part number 6595.50.035 and lot number 18at0ub, no pre-existing anomaly was found on the items manufactured with the same lot number.Based on the available records, at least (b)(4) items belonging to the part number 6595.50.035 and lot number 18at0ub have been implanted, and this is the first and only complaint received on this lot number.Neither removed components nor x-rays were available to be shared with the manufacturer.Therefore, no additional investigation can be carried out on this event.However, taking into account that: - no pre-existing anomalies has been discovered by checking the manufacturing charts of the items belonging to the part number 6595.50.035 and lot number 18at0ub.We have no evidence to consider the event as product related.Pms data: according to the relevant pms data, this is the only complaint received on a revision surgery that involved patella prostheses belonging to the family code 6595.50.0xx due to disassembly of component.This means that the revision rate is lower than (b)(4).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
• Common Device Name: PATELLAR PROSTHESIS DIA. 35MM
• 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: 22114069
• Report Number: 3008021110-2025-00064
• Device Sequence Number: 12551890
• Product Code: JWH
• UDI-Device Identifier: 08033390091022
• UDI-Public: 08033390091022
• Combination Product (Y/N): N
• PMA/510(K) Number: K141934
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 05/30/2025

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: 6595.50.035
• Device Lot Number: 18AT0UB
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/30/2025
• 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