MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/10 MM R; KNEE FIXED TIBIAL INSERT

Model Number	02.12.0210FR
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 11 may 2021: lot 140345: (b)(4) items manufactured and released on 03-apr-2014.Expiration date: 2019-02-28.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 since 2017.Additional implant involved: gmk-sphere 02.07.1202r tibial tray fixed cemented size 2 r (k090988) lot.160017.Batch review performed on 11 may 2021: lot 160017: (b)(4) items manufactured and released on 10-mar-2016.Expiration date: 2021-02-27.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 since 2017.
Event or Problem Description
The patient came in for a post-op appointment and it was observed that the tibial insert screw had disengaged and ended up inside of the tissue.It was also observed that the tibial insert screw had caused damage to the unresurfaced patella.4 years and 6 months after primary the surgeon revised the liner, tibial tray and added an extension stem and patella.The surgery was completed successfully.When the surgeon operated on the patient, it was observed that the tibial tray was also loose, so the surgeon revised it.A torque limiting screwdriver was not used during the primary.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/10 MM R
• Common Device Name: KNEE FIXED TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11906932
• Report Number: 3005180920-2021-00460
• Device Sequence Number: 1296730
• Product Code: JWH
• UDI-Device Identifier: 07630030826146
• UDI-Public: 07630030826146
• Combination Product (Y/N): N
• 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: 2016
• 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): 05/31/2021

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: 02/28/2019
• Device Model Number: 02.12.0210FR
• Device Catalogue Number: 02.12.0210FR
• Device Lot Number: 140345
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2021
• Initial Report FDA Received Date: 05/31/2021
• 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