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

Model Number	02.12.0210FR
Health Effect - Clinical Code	Sepsis (2067)
Date of Event	10/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 17-nov-2020: lot 131515: (b)(4) items manufactured and released on 03-may-2013.Expiration date: 31-mar-2018.No anomalies found related to the problem to date, 29 items of the same lot have been already sold without any other similar reported event since 2016 considering the unscrewing and the infection.Clinical evaluation: 5 years after primary cemented total knee arthroplasty, the insert fixation screw got loose in the joint.The cause for self-unscrewing of the insert screw is not known: one possibility is insufficient tightening torque, but other unknown conditions may also play a role.
Event or Problem Description
During the standard follow-up check, the tibial insert fixation screw was found loose in the joint.The screw has been arthroscopically revised on (b)(6) 2020, 4 years and 11 months after the primary surgery.On (b)(6) 2020 some tissue, through an arthroscopic procedure, has been extracted to check if the patient was septic.On (b)(6) 2020 they changed the inlay due to sepsis.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 2/10 MM R
• Common Device Name: TIBIAL INSERT FIXED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10852283
• Report Number: 3005180920-2020-00802
• Device Sequence Number: 641122
• Product Code: JWH
• UDI-Device Identifier: 07630030826146
• UDI-Public: 07630030826146
• Combination Product (Y/N): Y
• Initial Reporter Country: AU
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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): 11/17/2020

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: 03/31/2018
• Device Model Number: 02.12.0210FR
• Device Catalogue Number: 02.12.0210FR
• Device Lot Number: 131515
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2020
• Initial Report FDA Received Date: 11/17/2020
• 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: 72 YR