MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2; KNEE TIBIAL TRAY

Model Number	02.07.1202L
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/30/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 01-sep-2022: lot 2009462: (b)(4) items manufactured and released on 21-dec-2020.Expiration date: 2025-12-08.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of the review.Additional device involved: batch review performed on 01-sep-2022: gmk-sphere 02.12.0212fl tibial insert fixed sphere flex size 2/12 mm l (k121416) lot 2000386: (b)(4) items manufactured and released on 26-feb-2020.Expiration date: 2025-02-12.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of the review.Clinical evaluation performed by medacta medical affairs director: few weeks after primary cemented tka the tibial tray is reported painful and found mobilized.The case is rather extreme in terms of alignment, but this can hardly be the proven cause of the loosening.Seeing that no cement adhered at all to the baseplate, we are more inclined to ascribe to a cementation problem the main cause of mobilization: for example, liquid interposed between cement and tray, or an unexpected delay in the apposition of cement on the undersurface of the tray could have caused a similar effect, as well as unexpectedly high temperature of the room that may have hastened curing of the cement.We cannot determine with certainty the causes of this adverse event with the information at hand.Preliminary investigation performed by medacta knee project manager: revision surgery of a gmk sphere implant after 1 month and 3 weeks from primary implantation due to aseptic loosening.The investigation is based on the picture of the explanted tibial tray, in which no residual cement can be noted on the distal surface of the tibial baseplate.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).The absence of cement on the distal surface is not evidence of a faulty device.
Event or Problem Description
At about 1 month and 3 weeks after the primary surgery, the patient came in reporting pain due to aseptic loosening of the tibia and the cause is unknown.The surgeon revised the tibial tray and insert.The surgery was completed successfully.

• Brand Name: GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2
• Common Device Name: KNEE 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: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 15485483
• Report Number: 3005180920-2022-00729
• Device Sequence Number: 5286285
• Product Code: JWH
• UDI-Device Identifier: 07630030819865
• UDI-Public: 07630030819865
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 09/26/2022

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: 12/08/2025
• Device Model Number: 02.07.1202L
• Device Catalogue Number: 02.07.1202L
• Device Lot Number: 2009462
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2022
• Initial Report FDA Received Date: 09/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/21/2020
• 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