MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/17 MM L; FIXED TIBIAL INSERT

Model Number	02.12.0417FL
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	12/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 21 december 2021: lot 163360: 25 items manufactured and released on 12-sep-2016.Expiration date: 2021-aug-30.No anomalies found related to the problem.To date, 11 items of the same lot have been sold with no similar reported event since 2017.Additional implant involved: gmk-sphere 02.07.1204l tibial tray fixed cemented size 4 l (k090988) lot.187284.Batch review performed on 21 december 2021: lot 187284: 59 items manufactured and released on 10-dec-2018.Expiration date: 2023-nov-27.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event.
Event or Problem Description
The patient had a primary knee surgery on (b)(6) 2019.On (b)(6) 2019, the patient came in due to instability which was caused by exercising.The surgeon revised the medacta 12mm poly with a medacta 17mm poly and the surgery was completed successfully.Presently, on (b)(6) 2021, 2 years and 5 months after the previous surgery, the patient came in reporting laxity in the knee.When revising the insert, it was noticed that the tibia was loose.The surgeon revised the tibial tray and insert.The surgery was completed successfully.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/17 MM L
• Common Device Name: FIXED TIBIAL INSERT
• 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: 13265673
• Report Number: 3005180920-2022-00019
• Device Sequence Number: 4796290
• Product Code: JWH
• UDI-Device Identifier: 07630030826658
• UDI-Public: 07630030826658
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/17/2022

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: 08/30/2021
• Device Model Number: 02.12.0417FL
• Device Catalogue Number: 02.12.0417FL
• Device Lot Number: 163360
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2021
• Initial Report FDA Received Date: 01/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/12/2016
• 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: Male