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

Model Number	02.12.0411CRR
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	06/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient came in reporting instability and the cause is unknown.At about 3 years and 7 months post primary the surgeon revised the insert (from 11 to 13 mm) and the surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 12 june 2023: lot 188611: 100 items manufactured and released on 12-feb-2019.Expiration date: 2024-01-27.No anomalies found related to the problem.To date, 81 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 CR SIZE 4/11 MM R
• Common Device Name: KNEE 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: 17247477
• Report Number: 3005180920-2023-00483
• Device Sequence Number: 12439566
• Product Code: JWH
• UDI-Device Identifier: 07630040707503
• UDI-Public: 07630040707503
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K181635
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 07/03/2023

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: 01/27/2024
• Device Model Number: 02.12.0411CRR
• Device Catalogue Number: 02.12.0411CRR
• Device Lot Number: 188611
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2023
• Initial Report FDA Received Date: 07/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/12/2019
• 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: Male