MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE 02.12.0510FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM R; KNEE TIBIAL INSERT

Catalog Number	02.12.0510FR
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	03/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 21-mar-2024.Lot 2212770: (b)(4) items manufactured and released on 03-aug-2022.Expiration date: 2027-07-14.No anomalies found related to the problem.To date, all the items of the same lot have been sold with another similar reported event during the period of review.Other device involved: gmk-sphere 02.07.1205r tibial tray fixed cemented size 5 r (k090988) lot 2212675: (b)(4) items manufactured and released on 06-sep-2022.Expiration date: 2027-08-24.No anomalies found related to the problem.To date, all the items of the same lot have been sold with no similar reported event during the period of review.
Event or Problem Description
At about 1 year and 3 months after primary, the patient came in reporting discomfort due to the inability to reach full flexion and the cause is unknown.The surgeon revised the insert and tibia.The surgery was completed successfully.

• Brand Name: GMK-SPHERE 02.12.0510FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM R
• 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: 19077268
• Report Number: 3005180920-2024-00210
• Device Sequence Number: 5897485
• Product Code: JWH
• UDI-Device Identifier: 07630030826740
• UDI-Public: 07630030826740
• 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: 2022
• Device Explanted Year: 2024
• 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): 04/10/2024

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 Catalogue Number: 02.12.0510FR
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2024
• Initial Report FDA Received Date: 04/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/03/2022
• 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: 51 YR
• Patient Sex: Male