MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3 R; KNEE CEMENTED TIBIAL TRAY

Model Number	02.07.1203R
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	09/29/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 6 years 3 months after the primary, the patient had an instability of the right knee.The surgeon tried to increase the inlay to restore the required stability.He didn´t achieve this stability and revised also the femur and tibia.
Additional Manufacturer Narrative
Batch review performed on 29 december 2022: lot 162463: (b)(4) items manufactured and released on 17-june-2016.Expiration date: 2021-06-07.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Batch review performed on 29 december 2022: gmk-sphere 02.12.0003r femoral component sphere cemented size 3 r (k121416) lot 162681: (b)(4) items manufactured and released on 09-june-2016.Expiration date: 2021-05-22.No anomalies found related to the problem.To date, 58 items of the same lot have been sold with another similar reported event during the period of review.Gmk-sphere 02.12.0310fr tibial insert fixed sphere flex size 3/10 mm r (k121416) lot 163068: (b)(4) items manufactured and released on 28-july-2016.Expiration date: 2021-07-18.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event during the period of review.Investigation performed by medacta r&d knee project manager: revision surgery of a gmk sphere implant due to instability after six years from primary implantation.Surgeons tried to increase the poly height but that was not sufficient to solve the instability.Preliminary investigation based on the pictures sent of the explanted femur, tibia and insert.From preliminary investigation we can't notice any anomalies that could have played a role in the event.We can see some dents and scratches on the components most likely caused during the revision surgery.From preliminary investigation, there is no evidence that the event was related to a faulty device.

• Brand Name: GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3 R
• Common Device Name: KNEE 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: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 16240592
• Report Number: 3005180920-2022-01005
• Device Sequence Number: 20484447
• Product Code: JWH
• UDI-Device Identifier: 07630030819896
• UDI-Public: 07630030819896
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 01/25/2023

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: 06/07/2021
• Device Model Number: 02.07.1203R
• Device Catalogue Number: 02.07.1203R
• Device Lot Number: 162463
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2022
• Initial Report FDA Received Date: 01/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/17/2016
• 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