MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL TRAY CEMENTED T3I4R TINBN COATED; KNEE CEMENTED TIBIAL TRAY

Model Number	02.12.28T3I4R
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/17/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 16 february 2022: lot 2013564: (b)(4) items manufactured and released on 12-apr-2021.Expiration date: 2026-03-25.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Additional device involved batch review performed on 16 february 2022: lot 2012064: (b)(4) items manufactured and released on 05-mar-2021.Expiration date: 2026-02-22.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Clinical evaluation performed by medacta medical affairs director: revision after 7 months of a cemented tka on a female patient.From the radiographic image provided, the knee alignment is identified as valgus.On the basis of the available information we cannot determine if this was a surgeon's choice or due to a technical error.Some loose cement had been left in the surrounding area after first surgery and the revision operation is a good opportunity to clean it.The reason for this revision is repositioning, not an implant defect or malfunction.
Event or Problem Description
Complete revision of tka implants because of incorrect implantation.The main problem was, the patient's leg was initial in the varus and after the primary surgery, it was in the valgus.Another problem was some loose cement that had been left in the surrounding area.At 8 months from primary the surgeon changed the angle of the knee and implanted a new gmk-sphere.

• Brand Name: GMK-SPHERE TIBIAL TRAY CEMENTED T3I4R TINBN COATED
• Common Device Name: KNEE CEMENTED TIBIAL TRAY
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 13541410
• Report Number: 3005180920-2022-00098
• Device Sequence Number: 4299278
• Product Code: JWH
• UDI-Device Identifier: 07630040711630
• UDI-Public: 07630040711630
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K202684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• 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): 02/16/2022

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: 03/25/2026
• Device Model Number: 02.12.28T3I4R
• Device Catalogue Number: 02.12.28T3I4R
• Device Lot Number: 2013564
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2022
• Initial Report FDA Received Date: 02/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/12/2021
• 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 Sex: Female