MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 4/14MM L; TIBIAL INSERT FIXED

Catalog Number	02.07.0414PSF
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/01/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 25 may 2018: lot 123060: (b)(4) items manufactured and released on 14 november 2012.Expiration date: 2017-09-30.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.Clinical evaluation performed by medical affairs director on 18 may 2018: two years after primary total knee arthroplasty, the insert fixation screw was found loose from the tibial insert.Radiographic images provided show incomplete unscrewing.The existing screw can be repositioned but the use of a new one is strongly recommended.The reason for self unscrewing of the insert fixation screw is unknown: one possibility is insufficient tightening torque but other conditions may have contributed.
Event or Problem Description
Revision surgery due to inlay locking screw unscrewing after about 2 years and 2 months after primary.The surgeon refixate the screw through a "mini-open" approach.

• Brand Name: GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 4/14MM L
• Common Device Name: TIBIAL INSERT FIXED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7544761
• Report Number: 3005180920-2018-00372
• Device Sequence Number: 18876127
• Product Code: JWH
• UDI-Device Identifier: 07630030817847
• UDI-Public: 07630030817847
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/30/2018

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: 09/30/2017
• Device Catalogue Number: 02.07.0414PSF
• Device Lot Number: 123060
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2018
• Initial Report FDA Received Date: 05/25/2018
• 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