MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/11 MM R; KNEE TIBIAL LINER

Model Number	02.12.0411FR
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	06/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 13 july 2022: lot 1909435: 50 items manufactured and released on 03-dec-2019.Expiration date: 2024-11-18.No anomalies found related to the problem.To date, 43 items of the same lot have been sold without any similar reported event during the period of review.Additional device involved batch review performed on 13 july 2022: gmk-sphere 02.12.0024r femoral component sphere cemented size 4+ r (k140826) lot 2105307: 70 items manufactured and released on 23-june-2021.Expiration date: 2026-06-09.No anomalies found related to the problem.To date, 59 items of the same lot have been sold without any similar reported event during the period of review.
Event or Problem Description
At 9 months after the primary, the patient came in reporting instability due to laxity.The surgeon revised the 11mm poly with a 17mm poly and revised the femoral component.The surgery was completed successfully.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/11 MM R
• Common Device Name: KNEE TIBIAL LINER
• 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: 15025735
• Report Number: 3005180920-2022-00542
• Device Sequence Number: 6856981
• Product Code: JWH
• UDI-Device Identifier: 07630030862625
• UDI-Public: 07630030862625
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K140826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• 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): 07/15/2022

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: 11/18/2024
• Device Model Number: 02.12.0411FR
• Device Catalogue Number: 02.12.0411FR
• Device Lot Number: 1909435
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2022
• Initial Report FDA Received Date: 07/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/03/2019
• 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: Female