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	Tissue Damage (2104)
Date of Event	10/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 15 october 2020: lot 171842: (b)(4) items manufactured and released on 25-lul-2017.Expiration date: 2022-07-16.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Clinical evaluation: loosening of tibial baseplate in a cemented tka performed two years before.The explanted devices had been implanted as revision of previous similar components.No indication of a defect in the procedure is visible on the xrays.Aseptic loosening is a possible adverse event following tka, described in literature.No evidence of a device defect.The root cause of this event could not be determined.Other devices involved in the event: gmk-sphere 02.12.0412fr gmk-sphere tibial insert - flex s4r - 12 mm lot.174808 (k121416) batch review performed on 15 october 2020.Lot 174808: (b)(4) items manufactured and released on 14-aug-2017.Expiration date: 2022-07-19.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
Event or Problem Description
Second revision surgery performed after 5 months from the previous revision surgery due to the mobilization of the tibial tray.The surgeon revised the tibial tray, the liner and the patella implant.During the first revision surgery performed after 1 year and 5 months after the primary surgery, the surgeon revised the liner from 12 mm(lot 174808) to 17 mm (lot 154783) and add the patella implant due to knee instability and patellar chondropathy.

• 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: 10875437
• Report Number: 3005180920-2020-00814
• Device Sequence Number: 14281877
• Product Code: JWH
• UDI-Device Identifier: 07630030827143
• UDI-Public: 07630030827143
• Combination Product (Y/N): Y
• Initial Reporter Country: SZ
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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
• Report Date (Section B): 11/20/2020

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: 07/16/2022
• Device Model Number: 02.12.T3I4R
• Device Catalogue Number: 02.12.T3I4R
• Device Lot Number: 171842
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2020
• Initial Report FDA Received Date: 11/20/2020
• 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: 71 YR
• Patient Weight: 80