MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 3/10MM; KNEE TIBIAL LINER

Catalog Number	02.07.0310PSF
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 8 november 2019: lot 121448: (b)(4) items manufactured and released on 10-aug-2012.Expiration date: 2017-06-30.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.Clinical evaluation performed by medacta medical affairs director: 6 years after primary cemented tka the insert fixation screw is found loose posterior to the articulating surfaces.It is very possible that the screw has backed out long before it was detected because it is in a position where it is probably completely asymptomatic.The reason for the self-unscrewing could be insufficient tightening torque at surgery, but other causes may play a role.We do not see other reasons that could suggest a total revision of the implants.The decision on the opportunity for a surgery aimed at removing the screw is up to the surgeon exclusively.From the technical point of view, it is very likely that a 10mm thick insert may work well indefinitely in absence of such screw, particularly because it has already done so.
Event or Problem Description
During an ambulance visit in the hospital lkh-stolzalpe on (b)(6) 2019, the physician dr.(b)(6) detected the loose inlay fixation screw in the back of the joint on the x-ray pictures.Revision surgery has been then performed, more than 6 years after primary surgery.All components have been successfully revised.

• Brand Name: GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 3/10MM
• Common Device Name: KNEE TIBIAL LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9383331
• Report Number: 3005180920-2019-00986
• Device Sequence Number: 2499571
• Product Code: JWH
• UDI-Device Identifier: 07630030817069
• UDI-Public: 07630030817069
• 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: 2013
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/27/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2017
• Device Catalogue Number: 02.07.0310PSF
• Device Lot Number: 121448
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2019
• Initial Report FDA Received Date: 11/27/2019
• 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: Required Intervention
• Patient Age: 63 YR