MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 6 R

Model Number	02.07.1206R
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/10/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The primary tkr was done on (b)(6) 2018.The surgeon noticed the tibial tray was loose after investigating the patients x-rays.The patient could not be scheduled for surgery due to working responsibilities.The patient fell a few months after the consultation.The surgeon re-evaluated the x-rays and noticed the tibial tray was completely loose.Scheduled a revision surgery with (b)(6).The femoral compartment did not show signs of loosening.During the revision the surgeon noticed the femoral compartment was completely loose and he was able to remove it by hand.No cement was present on the implants.
Additional Manufacturer Narrative
Batch review performed on 12 october 2022.Lot: 168526: (b)(4) manufactured and released on 05-apr-2017.Expiration date: 2022-mar-26.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold with 1 similar reported event during the period of review.Clinical evaluation performed by medical affairs director: total knee revision 4.5 years after primary surgery.The revision was most likely due to a problem occurred during index surgery with cementation: it can be clearly seen that the cement did not interdigitate with the implant, but only with the bone.This phenomenon can typically happen if the metal implants are wet, or if there was an unexpected and unforeseen delay in the application of cement on the metal implants.Another possibility could be temperature in the or unusually high, which made the cement polymerize more quickly than expected.Visual inspection performed by r&d knee manager: total knee revision 4.5 years after primary surgery.The articular surface of both the tibial insert and the femoral component present scratches.These scratches can be caused by the third body caught between the two surfaces.The reason for the revision seems to be related to loose devices.No cement is present on the bottom surface of the explanted tibial tray and femoral component.Poor interdigitation between cement and implant can be related to multiple factors, most likely not implant related (such as the cementation process, temperature, time, and presence of fluids on the surfaces).The lack of cement adhering to the devices is not evidence of a faulty device.No other elements relevant to the event can be noted from visual inspection.Additional item involved in the event, batch review performed on 12 october 2022.Gmk-sphere 02.12.0026r femoral component sphere cemented size 6+ r lot: 172760 lot: 172760: (b)(4) manufactured and released on 06-oct-2017.Expiration date: 2022-sep-04.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold with no similar reported event during the period of review.

• Brand Name: GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 6 R
• Common Device Name: TIBIAL TRAY FIXED CEMENTED
• 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: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 15752030
• Report Number: 3005180920-2022-00818
• Device Sequence Number: 2958302
• Product Code: JWH
• UDI-Device Identifier: 07630030819957
• UDI-Public: 07630030819957
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• 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): 11/08/2022

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: 03/26/2022
• Device Model Number: 02.07.1206R
• Device Catalogue Number: 02.07.1206R
• Device Lot Number: 168526
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2022
• Initial Report FDA Received Date: 11/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2017
• 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: 56 YR
• Patient Sex: Male