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

Model Number 02.12.T3I4R

Device Problem Migration (4003)

Patient Problem Tissue Damage (2104)

Event Date 10/22/2020

Event Type  Injury  

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 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
• Type of Device: TIBIAL TRAY FIXED CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 10875437
• MDR Text Key: 217340571
• Report Number: 3005180920-2020-00814
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 07630030827143
• UDI-Public: 07630030827143
• Combination Product (y/n): Y
• Reporter Country Code: SZ
• PMA/PMN Number: K121416
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 10/22/2020
• Initial Date FDA Received: 11/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Weight: 80