MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 5/11 MM R; KNEE TIBIAL INSERT

Model Number	02.12.0511FR
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	02/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 19.February.2021: lot 174811: (b)(4) items manufactured and released on 27-nov-2017.Expiration date: 2022-11-09.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.
Event or Problem Description
The patient came in reporting instability and the cause of the instability is unknown.2 years and 2 months after primary the surgeon revised the sphere insert flex right 11mm s5 with a gmk-sphere tibial insert - flex s5r - 17mm to give the patient more stability.The surgery was completed successfully.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 5/11 MM R
• Common Device Name: KNEE TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11444816
• Report Number: 3005180920-2021-00182
• Device Sequence Number: 3523412
• Product Code: JWH
• UDI-Device Identifier: 07630030862663
• UDI-Public: 07630030862663
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K140826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• 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): 03/09/2021

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: 11/09/2022
• Device Model Number: 02.12.0511FR
• Device Catalogue Number: 02.12.0511FR
• Device Lot Number: 174811
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2021
• Initial Report FDA Received Date: 03/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention