MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/12 MM L

Catalog Number	02.12.0212FL
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 05 july 2019: lot 181878: (b)(4) items manufactured and released on 18-06-2018.Expiration date: 2023-05-21.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.Visual inspection performed by r&d knee manager: during the primary knee surgery and while attempting to engage the insert screw into the tibial tray, the surgeon observed that the screw would not engage with the tibial tray.The surgeon used another 12mm s2 sphere insert to complete the case.The surgery was then completed successfully.The returned tibial insert presents some dents and scratches on the anterior part, most likely caused during the handling of the insert in the attempt to insert, fix and remove the inlay from the joint.The hole of the screw seems to be in compliance with the specifications required.A functional test has been also performed to verify the possibility to engage the screw into the insert.As result of this test, it was possible to engage the dedicated screw and fix the inlay into the baseplate.From visual inspection of the returned insert, the isn't the evidence to link the event to a faulty device.Cause for the event remains unknown.
Event or Problem Description
During the primary knee surgery and while attempting to engage the insert screw into the tibial tray, the surgeon observed that the screw would not engage with the tibial tray.The surgeon used another 12mm s2 sphere insert to complete the case.The surgery was completed successfully.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/12 MM L
• Common Device Name: TIBIAL INSERT FIXED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8815009
• Report Number: 3005180920-2019-00592
• Device Sequence Number: 11383931
• Product Code: JWH
• UDI-Device Identifier: 07630030826177
• UDI-Public: 07630030826177
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/23/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/21/2023
• Device Catalogue Number: 02.12.0212FL
• Device Lot Number: 181878
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2019
• Initial Report FDA Received Date: 07/23/2019
• 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