MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE FIXED TIBIAL INSERT SIZE 4/12MM; KNEE TIBIAL INSERT

Model Number	02.09.0412H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 07 july 2021: lot 1902565: (b)(4) items manufactured and released on 6-may-2019.Expiration date: 2024-04-15.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without similar reported event.Clinical evaluation: a tka patient, who underwent probably multiple revision surgeries in the past, shows a fragment of a broken screw at the control xray.The broken screw could be coming from the post linking tibia and femur, but it could also belong to a former implantation.At this moment, revision has not yet been decided.The information available is not sufficient to perform a thorough analysis.If revision is undertaken, more information can be derived as to the origin of the broken screw.
Event or Problem Description
Breakage of the post screw implanted in (b)(6) 2020.The primary with competitor implants was performed in 2007.In 2020 the patient had two revision surgeries, in (b)(6) 2020 (competitor implants were explanted and medacta hinge knee implanted due to infection) and in (b)(6) 2020 (a liner revision was performed due to infection).At this moment the revision surgery is not planned.

• Brand Name: GMK-HINGE FIXED TIBIAL INSERT SIZE 4/12MM
• Common Device Name: KNEE TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12165055
• Report Number: 3005180920-2021-00551
• Device Sequence Number: 1480401
• Product Code: KRO
• UDI-Device Identifier: 07630030825194
• UDI-Public: 07630030825194
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K130299
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 07/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/15/2024
• Device Model Number: 02.09.0412H
• Device Catalogue Number: 02.09.0412H
• Device Lot Number: 1902565
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2021
• Initial Report FDA Received Date: 07/14/2021
• 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: Other