MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE FIXED TIBIAL TRAY SIZE 5 R; KNEE TIBIA REVISION

Model Number	02.09.4005R
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/18/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs department.One year after a complex case of revision tka the cemented components become loose.The low-quality pictures included in the report show very low quality bones, possibly affected by some sort of osteomalacia, not mentioned in the report - a situation that certainly makes the fixation of a large constrained prosthesis very challenging.We can only hypothesize that the low quality of the bone made fixation impossible, because the implant position, albeit very challenging, appears correct.Batch review performed on 21 november 2022: lot 2101290: (b)(4) items manufactured and released on 09-june-2021.Expiration date: 2026-05-25.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.Other component involved: gmk-hinge 02.09.2604r femoral component size 4 r (k130299) lot 1904680: (b)(4) items manufactured and released on 25-sept-2019.Expiration date: 2024-09-07.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.
Event or Problem Description
Revision surgery at about 1 year and 1 month post primary due to the femur and tibial tray loosening.All components revised successfully.

• Brand Name: GMK-HINGE FIXED TIBIAL TRAY SIZE 5 R
• Common Device Name: KNEE TIBIA REVISION
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 15932990
• Report Number: 3005180920-2022-00923
• Device Sequence Number: 6563227
• Product Code: KRO
• UDI-Device Identifier: 07630030825606
• UDI-Public: 07630030825606
• 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: 2021
• Device Explanted Year: 2022
• 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): 12/07/2022

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: 05/25/2026
• Device Model Number: 02.09.4005R
• Device Catalogue Number: 02.09.4005R
• Device Lot Number: 2101290
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2022
• Initial Report FDA Received Date: 12/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/09/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male