MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION REVISION FIXED TIBIAL TRAY CEMENTED SIZE 4 L

Model Number	02.07.0684L
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 09 november 2021.Lot 122880: (b)(4) items manufactured and released on 24-oct-2012.Expiration date: 2017-09-30.No anomalies found related to the problem.Clinical evaluation performed by medical affairs director: 7 years after revision tka the patient fels pain at tibial level and requires further revision.On the tibial side, a cementless stabilization stem was implanted in a very complicated situation, with bone screws and cerclage wires and presumably a fractured tibia: we don't know if these multiple fractures were related to the joint surgeries or to traumatic events.However, the complicated tibial condition did hot heal perfectly or at least did not heal allowing good integration of the cementless components.No reason to suspect a faulty device at the origin of this reoperation.Additional item involved in the event, batch review performed on 09 november 2021: gmk-revision 02.07.2403l femur revision ps size3 l (k102437) lot.124304.Lot 124304: (b)(4) items manufactured and released on 27-dec-2012.Expiration date: 2017-11-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event since 2017.
Event or Problem Description
Revision surgery 7 years and 2 months after medacta knee implantation for femoral and tibial components loosening.

• Brand Name: GMK-REVISION REVISION FIXED TIBIAL TRAY CEMENTED SIZE 4 L
• Common Device Name: FIXED TIBIAL TRAY
• 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: 12947864
• Report Number: 3005180920-2021-00948
• Device Sequence Number: 4741585
• Product Code: JWH
• UDI-Device Identifier: 07630030819384
• UDI-Public: 07630030819384
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K123721
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2021
• 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): 12/07/2021

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: 09/30/2017
• Device Model Number: 02.07.0684L
• Device Catalogue Number: 02.07.0684L
• Device Lot Number: 122880
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2021
• Initial Report FDA Received Date: 12/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/24/2012
• 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: 80 YR
• Patient Sex: Female