MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERIKA TIBIAL TRAY FIXED CEMENTED SIZE 2 R; GMK PRIMARY TOTAL KNEE SYSTEM

Model Number	02.07.1202R
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	11/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 09 dec 2024: lot 2316140: (b)(4) items manufactured and released on 27-sept-2023.Expiration date: 2028-09-06.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.Additional devices involved: batch reviews performed on 09 dec 2024.Gmk-spherika 02.12.E0210fr tibial insert fixed sphere flex #2/10 mm r e-cross (k202022) lot 2242202: (b)(4) items manufactured and released on 14-dec-2022.Expiration date: 2027-11-28.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.Gmk-spherika 02.12.Ka03r femoral component spherika cemented s3r (k211004) lot 2337643: (b)(4) items manufactured and released on 03-nov-2023.Expiration date: 2028-10-05.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.Root cause: based on the information available no definitive root cause can be established, while there is no indication that any potential issue with the device may have caused or contributed to the event, and the device history record review does not indicate any potential manufacturing related issue.
Event or Problem Description
The patient had pain and was unable to fully extend their knee.He didn't listen/follow recovery instructions after surgery.At about 8 months post primary the surgeon decided to revise tibial tray, tibial insert, and femoral component from a gmk spherika to a gmk hinge.It is unknown why the surgeon decided to revise everything.The surgery was completed successfully.

• Brand Name: GMK-SPHERIKA TIBIAL TRAY FIXED CEMENTED SIZE 2 R
• Common Device Name: GMK PRIMARY TOTAL KNEE SYSTEM
• 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: 20900788
• Report Number: 3005180920-2024-01077
• Device Sequence Number: 5004711
• Product Code: JWH
• UDI-Device Identifier: 07630030819872
• UDI-Public: 07630030819872
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/11/2024

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 Model Number: 02.07.1202R
• Device Lot Number: 2316140
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2024
• Initial Report FDA Received Date: 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/27/2023
• 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: 70 YR
• Patient Sex: Female