MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/14MM; FIXED TIBIAL INSERT SEMICONSTRAINED

Model Number	02.07.0414SCF
Health Effect - Clinical Codes	Fall (1848); Pain (1994)
Date of Event	03/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 25-mar-2021: lot 167087: (b)(4) items manufactured and released on 25-jan-2017.Expiration date: 2022-01-08.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Visual inspection performed by medacta r&d department: revision surgery after 3 years from implantation of a gmk revision implant due to pain after patient fall.Only tibial insert was revised with a thicker one.X-rays pre-op shows that the tibial insert screw was unscrewed.From visual inspection of the returned explanted components, tibial insert and relative screw don't present any damages and are in compliance with the specifications required.Based on the available information it is not possibile to assess if the cause for unscrewing is related to the patient fall or to factors could had played a role in the event.Clinical evaluation performed by medacta medical affairs department: less than 2 years after revision tka the patient falls and the knee becomes unstable.At revision, the surgeon finds a loose screw.The loose screw may have contributed to give the feeling of instability, but it's also possible that loose ligaments contributed too - in fact, the surgeon changed the insert to a thicker one.We cannot tell if the traumatic episode was the main cause for the adverse event or if it was only a concomitant factor.A full explanation cannot be supplied with certainty.
Event or Problem Description
The patient had a unicompartmental knee implanted in 2016 that was revised with medacta implants in 2017.Now, the patient fell on his knee and came in with pain.The metal peg of the inlay has been found unscrewed (after about 3 years and 5 months from the previous surgery).During the last revision surgery, the surgeon changed the insert to a higher one (17mm) and tightened the screw.

• Brand Name: GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/14MM
• Common Device Name: FIXED TIBIAL INSERT SEMICONSTRAINED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11575060
• Report Number: 3005180920-2021-00237
• Device Sequence Number: 3460528
• Product Code: JWH
• UDI-Device Identifier: 07630030817878
• UDI-Public: 07630030817878
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K103170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 03/26/2021

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: 01/08/2022
• Device Model Number: 02.07.0414SCF
• Device Catalogue Number: 02.07.0414SCF
• Device Lot Number: 167087
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2021
• Initial Report FDA Received Date: 03/26/2021
• 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
• Patient Age: 57 YR