MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/12 MM R; KNEE TIBIAL INSERT

Model Number	02.12.0212FR
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	05/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery for knee instability at about 4 years and 7 months post-primary.Liner was revised successfully with a thicker one (from 12mm to 17mm).
Additional Manufacturer Narrative
Batch review performed on 30 may 2023: lot 173798: 30 items manufactured and released on 15-sep-2017.Expiration date: 2022-08-23.No anomalies found related to the problem.To date, 22 items of the same lot have been sold without any similar reported event in the period of review.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/12 MM R
• Common Device Name: KNEE TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 17161348
• Report Number: 3005180920-2023-00443
• Device Sequence Number: 17596991
• Product Code: JWH
• UDI-Device Identifier: 07630030826184
• UDI-Public: 07630030826184
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2023
• 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): 06/20/2023

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: 08/23/2022
• Device Model Number: 02.12.0212FR
• Device Catalogue Number: 02.12.0212FR
• Device Lot Number: 173798
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2023
• Initial Report FDA Received Date: 06/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/15/2017
• 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: 77 YR
• Patient Sex: Female