MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 R; KNEE CEMENTED TIBIAL TRAY

Model Number	02.12.T3I4R
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 16.04.2021: lot 155154: (b)(4) items manufactured and released on 25-may-2016.Expiration date: 01-12-2020.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any other reported event since 2017.Clinical evaluation performed by medacta medical affairs director: 3 years after primary cemented tka the tibial plateau gets loose.It appears to be a case of idiopathic aseptic loosening, which is a possible adverse event following tka.The causes remain often undetermined, and also in this case we do not have enough information to draw a final conclusion.Visual inspection performed by medacta r&d manager: revision surgery of a gmk sphere implant after 2 years and 3 months from primary due to tibial subsidence.Tibial baseplate and insert have been removed and sent to medacta for inspection.No residual cement can be seen on the explanted tibia component.Cement most likely remained adherent to the bone and/or was removed during washing of the component after explantation.Some scratches can be seen on the medial distal edge of the component most likely caused during the detachment of the component from the bone.From visual inspection there is no evidence that the event was related to a faulty device.
Event or Problem Description
Revision surgery 3 years and 3 months after the primary for tibial plateau subsidence.The surgeon revised successfully the tibial components.

• Brand Name: GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 R
• Common Device Name: KNEE CEMENTED TIBIAL TRAY
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11770222
• Report Number: 3005180920-2021-00354
• Device Sequence Number: 14334409
• Product Code: JWH
• UDI-Device Identifier: 07630030827143
• UDI-Public: 07630030827143
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• 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): 05/04/2021

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: 12/01/2020
• Device Model Number: 02.12.T3I4R
• Device Catalogue Number: 02.12.T3I4R
• Device Lot Number: 155154
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2021
• Initial Report FDA Received Date: 05/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Weight: 89