MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE 02.12.0610FL TIBIAL INSERT FIXED SPHERE FLEX #6/10 MM L; KNEE TIBIAL INSERT

Model Number	02.12.0610FL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	04/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
About 1 year after the primary surgery, the patient was revised due to knee instability.The liner was revised from a 10mm to a 13mm.During the revision, circular incisions were noted on the medial and lateral compartments of the explanted liner.Also, cement particles were found on the patella.
Additional Manufacturer Narrative
Batch review performed on 21 april 2023.Lot 1906882: (b)(4) items manufactured and released on 09-oct-2019.Expiration date: 2024-sep-21.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Analysis performed by r&d manager: revision surgery of a gmk sphere implant after 1 year from primary implantation due to instability.In the revision surgery, the liner was substituted with a thicker one.From the picture of the explanted tibial insert, we can notice some 'circular' dents on the articular surfaces of the liner.Those dents are unusual to be seen, particularly in a liner that has been implanted for one year, and could have been most likely caused by a third body (i.E.Cement particles that were actually found in the articulation during the revision surgery) that was interposed between the liner and the femoral component.Looking at the picture of the explanted tibial insert, there is no evidence that the event is related to a faulty device.

• Brand Name: GMK-SPHERE 02.12.0610FL TIBIAL INSERT FIXED SPHERE FLEX #6/10 MM L
• 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: 16960272
• Report Number: 3005180920-2023-00350
• Device Sequence Number: 20206483
• Product Code: JWH
• UDI-Device Identifier: 07630030826931
• UDI-Public: 07630030826931
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 05/19/2023

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: 09/21/2024
• Device Model Number: 02.12.0610FL
• Device Catalogue Number: 02.12.0610FL
• Device Lot Number: 1906882
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2023
• Initial Report FDA Received Date: 05/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/09/2019
• 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 Age: 64 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White