MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE 02.07.1206R TIBIAL TRAY FIXED CEMENTED SIZE 6 R

Model Number	02.07.1206R
Health Effect - Clinical Codes	Necrosis (1971); Pain (1994)
Date of Event	04/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Anterior pain described by the patient.Patella necrosis.No infection but loosening of the femoral and tibial components.At 4 years and 8 month after the primary surgery, the surgeon revised all the components and resurfaced the patella bone.The system was changed from gmk-sphere implants to gmk-hinge; that's the reason for an insert changing.
Additional Manufacturer Narrative
Batch review performed on 8 april 2022.Lot 168526: (b)(4) items manufactured and released on 05-apr-2017.Expiration date: 2022-03-26.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event since 2018.Other device implanted: batch review performed on 8 april 2022.Gmk-sphere 02.12.0006r femoral component sphere cemented # 6 r (k121416) lot 168741: (b)(4) items manufactured and released on 22-mar-2017.Expiration date: 2022-mar-12.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event since 2018.

• Brand Name: GMK-SPHERE 02.07.1206R 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 ; 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: 14250758
• Report Number: 3005180920-2022-00313
• Device Sequence Number: 4398480
• Product Code: JWH
• UDI-Device Identifier: 07630030819957
• UDI-Public: 07630030819957
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 04/29/2022

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: 03/26/2022
• Device Model Number: 02.07.1206R
• Device Catalogue Number: 02.07.1206R
• Device Lot Number: 168526
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2022
• Initial Report FDA Received Date: 04/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/05/2017
• 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: 63 YR
• Patient Sex: Male
• Patient Weight: 150 KG