MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 R; CEMENTED TIBIAL TRAY

Model Number	02.12.T3I4R
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/11/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 12 april 2022.Lot 172763: 50 items manufactured and released on 20-sep-2017.Expiration date: 2022-sep-08.No anomalies found related to the problem.To date, 49 items of the same lot have been sold with no similar reported event since 2018.Additional implant involved: gmk-sphere 02.12.0410fr tibial insert fixed sphere flex size 4/10 mm r (k121416) lot.176177.Batch review performed on 12 april 2022.Lot 176177: 75 items manufactured and released on 29-dec-2017.Expiration date: 2022-dec-10.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event since 2018.
Event or Problem Description
Revision surgery performed 3 years and 8 months after the primary surgery due to instability on the medial part and loosening of the tibial plate.Instability of the knee with laxity on the medial part and loosening of the tibial plate.Insert and tibial tray revised and tibial wedges and extension stem added.

• Brand Name: GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 R
• Common Device Name: 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: 14336302
• Report Number: 3005180920-2022-00345
• Device Sequence Number: 6173494
• Product Code: JWH
• UDI-Device Identifier: 07630030827143
• UDI-Public: 07630030827143
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 05/09/2022

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: 09/08/2022
• Device Model Number: 02.12.T3I4R
• Device Catalogue Number: 02.12.T3I4R
• Device Lot Number: 172763
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2022
• Initial Report FDA Received Date: 05/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/20/2017
• 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: 51 YR
• Patient Sex: Female
• Patient Weight: 90 KG