MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE 02.12.0512FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/12 MM L; KNEE FIXED TIBIAL INSERT

Model Number	02.12.0512FL
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/15/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 26 july 2022: lot 2108922: (b)(4) items manufactured and released on 16-sept-2021.Expiration date: 2026-09-02.No anomalies found related to the problem.To date, 42 items of the same lot have been sold without any similar reported event during the period of review.Clinical evaluation performed by medical affairs director: less than 5 months after primary cemented tka the knee develops instability and requires substitution of the insert to a thicker one.The secondary onset of instability is a possible adverse event following tka, not related to a product deficiency.It can often be fully solved by recurring to a taller inlay, though it's impossible to say if the new solution will last for a long time.
Event or Problem Description
Revision surgery at about 5 months from primary for knee instability.The surgeon swapped the liner to a thicker one successfully.

• Brand Name: GMK-SPHERE 02.12.0512FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/12 MM L
• Common Device Name: KNEE 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: 15174143
• Report Number: 3005180920-2022-00602
• Device Sequence Number: 20413609
• Product Code: JWH
• UDI-Device Identifier: 07630030826771
• UDI-Public: 07630030826771
• 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: 2022
• 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): 08/05/2022

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: 09/02/2026
• Device Model Number: 02.12.0512FL
• Device Catalogue Number: 02.12.0512FL
• Device Lot Number: 2108922
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2022
• Initial Report FDA Received Date: 08/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/16/2021
• 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: 72 YR
• Patient Sex: Male
• Patient Weight: 80 KG