MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 2/10MM; TIBIAL INSERT FIXED

Catalog Number	02.07.0210PSF
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs manager on december 13, 2018 4,5 years after primary tkr the insert fixation screw got loose in the joint.It was immediately removed; screw and insert were replaced.Visual inspection of the articular surfaces during surgery can exclude possible damages to the femoral component.The cause for self-unscrewing of the insert fixation screw is unknown: one possibility is insufficient tightening torque, but other unknown conditions may also play a role.Batch review performed on 18 december 2018: lot 120682: (b)(4) items manufactured and released on 01 june 2012.Expiration date: 2017-04-30.No anomalies found related to the issue.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
Event or Problem Description
The patient came in due to instability, 4 years and 7 months after primary surgery, caused by the screw backing out of the insert.The torque limiting driver was not used in the primary surgery.The surgeon revised the insert and the surgery was completed successfully.

• Brand Name: GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 2/10MM
• Common Device Name: TIBIAL INSERT FIXED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8178707
• Report Number: 3005180920-2018-01013
• Device Sequence Number: 1203832
• Product Code: JWH
• UDI-Device Identifier: 07630030816482
• UDI-Public: 07630030816482
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/19/2018

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: 04/30/2017
• Device Catalogue Number: 02.07.0210PSF
• Device Lot Number: 120682
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2018
• Initial Report FDA Received Date: 12/19/2018
• 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