MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE 02.12.0022L FEMORAL COMPONENT SPHERE CEMENTED # 2+ L; FEMORAL COMPONENT CEMENTED

Model Number	02.12.0022L
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	03/03/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 25 march 2022.Lot 2106489: (b)(4) items manufactured and released on 29-jul-2020.Expiration date: 2026-07-04.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medical affairs director: early revision surgery, few months after primary, of a cemented tka due to difficulties in flexion.The new surgeon repositioned the femoral component, downsizing it by 1 size, and placed a slightly thicker insert, leaving the tibial component in place.This problem is not due to a device failure.Other device involved: batch review performed on 25 march 2022: gmk-sphere 02.12.0210fl tibial insert fixed sphere flex #2/10 mm l (k121416) lot 2104644: (b)(4) items manufactured and released on 08-jun-2021.Expiration date: 2026-05-24.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
Event or Problem Description
The femoral component and the inlay have been revised 4 months after primary, because the patient was not able to flex the knee and was not stable in extension.The femur was changed from a 2+ into a 1+ and the liner from 10mm to 12mm.

• Brand Name: GMK-SPHERE 02.12.0022L FEMORAL COMPONENT SPHERE CEMENTED # 2+ L
• Common Device Name: FEMORAL COMPONENT CEMENTED
• 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: 13976490
• Report Number: 3005180920-2022-00213
• Device Sequence Number: 11959331
• Product Code: JWH
• UDI-Device Identifier: 07630030862472
• UDI-Public: 07630030862472
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K140826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 04/01/2022

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: 07/04/2026
• Device Model Number: 02.12.0022L
• Device Catalogue Number: 02.12.0022L
• Device Lot Number: 2106489
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2022
• Initial Report FDA Received Date: 04/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/29/2020
• 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