MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 L; KNEE CEMENTED TIBIAL TRAY

Catalog Number	02.07.1205L
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Follow up in order to correct the product code (section d2b): it was reported jwk, but the correct code is jwh.
Additional Manufacturer Narrative
Batch review performed on 14 june 2024.Lot 174581: (b)(4) manufactured and released on 23-nov-2017.Expiration date: 2022-11-08.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event during the period of review.Preliminary analysis performed by r&d project manager from the analysis on pictures of the explanted components, no residual cement can be noted on the distal surface of tibial baseplate.Signs of wear can be noted on the medial articular surface of the tibial insert.No anomalies can be noted on the femoral component.Dents and scratches can be noted on the components most likely caused during the attempt to remove the implants.Poor interdigitation between cement and implant can be related to multiple factors, most likely not implant related (such as cementation process, temperature, time, presence of fluids on the surfaces of cement interface).Absence of cement, is not an evidence of a faulty device.Signs of wear could have been caused for relative tibio-femoral malpositioning when the tibia became loose.From preliminary investigation, there is no evidence to suspect that the event is related to a faulty device.
Event or Problem Description
Revision surgery at about 6 years 1 month after the primary due to aseptic loosening of the tibial component that caused the wear and tear of the liner on the medial side.The surgeon revised successfully tibial component, insert and femoral component.
Additional Manufacturer Narrative
Visual inspection performed by r&d project manager from visual investigation based on received explanted components, no residual cement can be noted on the distal surface of tibial baseplate.Signs of wear can be noted on the medial articular surface of the tibial insert.The medial edge of the articular surface looks pressed like if the femur was articulating on that.No anomalies can be noted on the femoral component.Dents and scratches can be noted on the components most likely caused during the attempt to remove the implants.Poor interdigitation between cement and implant can be related to multiple factors, most likely not implant related (such as cementation process, temperature, time, presence of fluids on the surfaces of cement interface).Absence of cement, is not an evidence of a faulty device.Signs of wear could have been caused for relative tibio-femoral malpositioning when the tibia became loose.There is no evidence to suspect that the event is related to a faulty device.Batch review performed on 21 august 2024 on gmk-sphere 02.12.0512fl tibial insert fixed sphere flex size 5/12 mm l (k121416) lot.162169 lot 162169: (b)(4) items manufactured and released on 23-nov-2017.Expiration date: 2022-11-08.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Information reported in this second follow up: pieces returned on 19 august 2024.Visual inspection of the pieces batch of the liner.

• Brand Name: GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 L
• Common Device Name: KNEE CEMENTED TIBIAL TRAY
• 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: 19665066
• Report Number: 3005180920-2024-00486
• Device Sequence Number: 6623750
• Product Code: JWH
• UDI-Device Identifier: 07630030819926
• UDI-Public: 07630030819926
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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,Followup,Followup
• Report Date (Section B): 09/18/2024
• 2 Devices were Involved in the Event: 1 2

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: 11/08/2022
• Device Catalogue Number: 02.07.1205L
• Device Lot Number: 174581
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 07/03/2024
• Supplement Report FDA Received Date: 07/08/2024; 09/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/23/2017
• 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 Sex: Unknown