MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/12 MM R; KNEE TIBIAL INSERT FIXED

Model Number	02.12.0412FR
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	06/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery at about 1 year and 2 months post primary for knee instability.The surgeon explanted the liner thick 12mm and implanted a thicker liner of 17mm.
Additional Manufacturer Narrative
Batch review performed on 05 july 2022: lot 2002795: 75 items manufactured and released on 10-june-2020.Expiration date: 2025-06-01.No anomalies found related to the problem.To date, 62 items of the same lot have been sold without any similar reported event during the period of review.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/12 MM R
• Common Device Name: KNEE TIBIAL INSERT FIXED
• 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: 15037411
• Report Number: 3005180920-2022-00553
• Device Sequence Number: 17878278
• Product Code: JWH
• UDI-Device Identifier: 07630030826580
• UDI-Public: 07630030826580
• 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: 2021
• 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): 07/18/2022

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 Model Number: 02.12.0412FR
• Device Catalogue Number: 02.12.0412FR
• Device Lot Number: 2002795
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2022
• Initial Report FDA Received Date: 07/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/10/2020
• 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: 64 YR
• Patient Sex: Female
• Patient Race: White