MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/12 MM L; KNEE INSERT

Catalog Number	02.12.0412FL
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Joint Laxity (4526); Implant Pain (4561)
Date of Event	11/06/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 1 year 11 months after the primary, the patient came in reporting pain due to a loose tibia and knee instability and the cause is unknown.The surgeon revised the tibial tray and insert (12 to 20 mm) and the surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 08 november 2023: lot 2104742: (b)(4) items manufactured and released on 04-june-2021.Expiration date: 2026-05-16.No anomalies found related to the problem.To date, 67 items of the same lot have been sold without any similar reported event during the period of review.Additional implant involved, batch review performed on 08 november 2023: gmk-sphere 02.07.1204l tibial tray fixed cemented # 4 l (k090988) lot 2104558: (b)(4)manufactured and released on 29-june-2021.Expiration date: 2026-07-18.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event during the period of review.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/12 MM L
• 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: 18246116
• Report Number: 3005180920-2023-00924
• Device Sequence Number: 6582794
• Product Code: JWH
• UDI-Device Identifier: 07630030826573
• UDI-Public: 07630030826573
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/01/2023

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: 05/16/2026
• Device Catalogue Number: 02.12.0412FL
• Device Lot Number: 2104742
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2023
• Initial Report FDA Received Date: 12/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/04/2021
• 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 Sex: Female