MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 6 R

Model Number	02.07.1206R
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 08 april 2022: lot 2013153: 53 items manufactured and released on 23-april-2021.Expiration date: 2026-04-12.No anomalies found related to the problem.To date, 24 items of the same lot have been sold without any similar reported event.
Event or Problem Description
Revision surgery at 6 months from primary due to tibial tray fixed cemented loosening.Tibial tray and liner swapped successfully.

• Brand Name: GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 6 R
• Common Device Name: TIBIAL TRAY FIXED CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; CH 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: 14268869
• Report Number: 3005180920-2022-00336
• Device Sequence Number: 4439407
• Product Code: JWH
• UDI-Device Identifier: 07630030819957
• UDI-Public: 07630030819957
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/02/2022

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: 04/12/2026
• Device Model Number: 02.07.1206R
• Device Catalogue Number: 02.07.1206R
• Device Lot Number: 2013153
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2022
• Initial Report FDA Received Date: 05/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/23/2021
• 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: Male