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

Model Number	02.12.T3I4R
Health Effect - Clinical Code	Balance Problems (4401)
Date of Event	11/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 30 november 2020: lot 180377: (b)(4) items manufactured and released on 23-apr-2018.Expiration date: 2023-04-13.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
The patient came in reporting instability due an aseptic loosening of the tibial component.The surgeon planned to revise the tibial component and poly on (b)(6) 2020, 2 years and 1 month after primary, but the case had to be postponed due to the patient going into atrial fibrillation just prior to the start of the case.
Additional Manufacturer Narrative
The patient came in reporting instability due an aseptic loosening of the tibial component.The surgeon planned to revise the tibial component and poly on (b)(6) 2020, 2 years and 1 month after primary, but the case had to be postponed due to the patient going into atrial atrial fibrillation just prior to the start of the case.Revision surgery has not been performed yet.
Event or Problem Description
The patient came in reporting instability due an aseptic loosening of the tibial component.The surgeon planned to revise the tibial component and poly on (b)(6) 2020, 2 years and 1 month after primary, but the case had to be postponed due to the patient going into atrial atrial fibrillation just prior to the start of the case.Revision surgery has not been performed yet.

• Brand Name: GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 R
• Common Device Name: TIBIAL TRAY FIXED CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11037586
• Report Number: 3005180920-2020-00911
• Device Sequence Number: 13780052
• Product Code: JWH
• UDI-Device Identifier: 07630030827143
• UDI-Public: 07630030827143
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• 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
• Report Date (Section B): 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/13/2023
• Device Model Number: 02.12.T3I4R
• Device Catalogue Number: 02.12.T3I4R
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2020
• Supplement Date Received by Manufacturer: 11/18/2020
• Initial Report FDA Received Date: 12/18/2020
• Supplement Report FDA Received Date: 03/18/2021
• 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: Other