MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 5/14 MM R; KNEE TIBIAL INSERT

Model Number	02.12.0514FR
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	02/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 12.Feb.2021: lot 189062: (b)(4) items manufactured and released on 4-mar-2019.Expiration date: 2024-02-24.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
Event or Problem Description
Revision surgery was performed on (b)(6) 2021, 11 months after the primary surgery.The reason is instability.It is not confirmed which implants were revised but the surgeon planned before the revision to use a higher insert and to resurface patella bone.
Additional Manufacturer Narrative
On (b)(6) 2021 we have received the information that the revision surgery was cancelled.
Event or Problem Description
Revision surgery was initially planned for (b)(6)2021, 11 months after the primary surgery.The reason is instability.The surgeon planned to use a higher insert and to resurface patella bone.Finally, the surgery was cancelled.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 5/14 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: 11412241
• Report Number: 3005180920-2021-00161
• Device Sequence Number: 11877469
• Product Code: JWH
• UDI-Device Identifier: 07630030826825
• UDI-Public: 07630030826825
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2021

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: 02/24/2024
• Device Model Number: 02.12.0514FR
• Device Catalogue Number: 02.12.0514FR
• Device Lot Number: 189062
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2021
• Supplement Date Received by Manufacturer: 02/02/2021
• Initial Report FDA Received Date: 03/04/2021
• Supplement Report FDA Received Date: 06/01/2021
• 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