MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE TIBIAL TRAY FIX CEMENTED S4 RM; KNEE PARTIAL SYSTEM CEMENTED TIBIAL TRAY

Model Number	02.18.TF4.RM
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery at about 1 year and 7 months post primary for cemented tibial tray loosening.All components revised and gmk sphere was implanted successfully.
Additional Manufacturer Narrative
Batch review performed on 13 april 2023: lot 2103556: (b)(4) items manufactured and released on 27-may-2021.Expiration date: 2026-05-11.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.Clinical evaluation performed by medical affairs department: less than 2 years after uka, the tibial component creates pain and requires substitution.According to report, there may have been a problem between bone and cement.A feeble radiolucent line is barely visible beneath the tibial plateau.The poor interdigitation of cement to bone is a plausible cause for mobilization but it can hardly be debited to a faulty device.Preliminary investigation performed by r&d department:: revision surgery of a moto medial implant after 1 year and 7 months from primary implantation due to suspected tibia loosening.From picture of the explanted components.No anomalies can be noted.Residual cement can be seen on the implants, so probably the cement didn't adhere properly to the bone.There is no evidence to suspect that the loosening was related to a faulty device.

• Brand Name: MOTO PARTIAL KNEE TIBIAL TRAY FIX CEMENTED S4 RM
• Common Device Name: KNEE PARTIAL SYSTEM CEMENTED TIBIAL TRAY
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 16917557
• Report Number: 3005180920-2023-00323
• Device Sequence Number: 12482318
• Product Code: HSX
• UDI-Device Identifier: 07630030896767
• UDI-Public: 07630030896767
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K162084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/12/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/11/2026
• Device Model Number: 02.18.TF4.RM
• Device Catalogue Number: 02.18.TF4.RM
• Device Lot Number: 2103556
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2023
• Initial Report FDA Received Date: 05/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2021
• 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: 60 YR
• Patient Sex: Male