MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE 02.12.0511FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/11 MM L; KNEE TIBIAL INSERT FIXED

Model Number	02.12.0511FL
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	05/31/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 1 june 2022.Lot 2112476: (b)(4).Expiration date: 2026-sep-23.No anomalies found related to the problem.(b)(4).Clinical evaluation performed by medical affairs director a few weeks after primary tka in a rather difficult case, some articular instability is reported by the patient and the surgeon decides to replace the tibial insert with a thicker one.There is not reason to suspect a faulty device.Visual inspection performed by r&d project manager revision surgery of a gmk sphere implant due to mid-flexion instability after 1 month and a half from primary implantation.In the revision procedure, the surgeon removed the liner to insert a thicker one to enhance stability.From visual inspection of the explanted tibial insert sent back for inspection, some scratches can be noted on the articular surfaces of the tibial insert, extending in the anteroposterior direction.Those signs were most likely caused by the instruments used to remove the insert from the joint.No further anomalies can be noted on the component.From visual inspection, there is no evidence that the event is related to a faulty device.
Event or Problem Description
The patient had knee pain and a feeling of mid-flexion instability.About 1 month and a half after the previous surgery, the surgeon changed to a thicker inlay.The patient had the primary surgery on (b)(6) 2013 and already had two revision surgeries, on (b)(6) 2014 and on (b)(6) 2022.

• Brand Name: GMK-SPHERE 02.12.0511FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/11 MM L
• 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: 14873815
• Report Number: 3005180920-2022-00492
• Device Sequence Number: 12494978
• Product Code: JWH
• UDI-Device Identifier: 07630030862649
• UDI-Public: 07630030862649
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K140826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 06/30/2022

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 Expiration Date: 09/23/2026
• Device Model Number: 02.12.0511FL
• Device Catalogue Number: 02.12.0511FL
• Device Lot Number: 2112476
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2022
• Initial Report FDA Received Date: 06/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2021
• 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: 62 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Native Hawaiian Or Other Pacific Islander