MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY 02.07.0410PSF TIBIAL INSERT PS FIXED SIZE 4/10MM LOT. 2241247; KNEE TIBIAL INSERT PS FIXED

Catalog Number	02.07.0410PSF
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	10/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 25 october 2023: lot 2241247: (b)(4) items manufactured and released on 03-jan-2023.Expiration date: 2027-12-06.No anomalies found related to the problem.To date, 22 items of the same lot have been sold without any similar reported event in the period of review.Clinical evaluation performed by medical affairs director: few weeks after primary cemented tka the whole system needs to be revised.From the images supplied, the position of the femoral component is suboptimal, with particular reference to the patellar bone.The tibial tray is aligned according to a criterion that is not specified in the report and that we were unable to identify.It also appears slightly undersized.We think that the root cause for this revision is suboptimal position of the primary components.Other devices involved: gmk-primary 02.07.12.1204l tibial tray fixed cemented size 4 l (k090988) lot 2212410: (b)(4) items manufactured and released on 28-sep-2022.Expiration date: 2027-09-12.No anomalies found related to the problem.To date, 22 items of the same lot have been sold without any similar reported event in the period of review.Gmk-primary 02.07.2205l femur ps cemented size 5 l (k090988) lot 1902638: (b)(4) items manufactured and released on 17-may-2019.Expiration date: 2024-05-06.No anomalies found related to the problem.To date, 22 items of the same lot have been sold without any similar reported event in the period of review.
Event or Problem Description
Revision surgery for knee stiffness at about 4 months from primary.All devices were revised successfully.

• Brand Name: GMK-PRIMARY 02.07.0410PSF TIBIAL INSERT PS FIXED SIZE 4/10MM LOT. 2241247
• Common Device Name: KNEE TIBIAL INSERT PS FIXED
• 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 18111209
• Report Number: 3005180920-2023-00885
• Device Sequence Number: 17531819
• Product Code: JWH
• UDI-Device Identifier: 07630030817649
• UDI-Public: 07630030817649
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 11/10/2023

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 Catalogue Number: 02.07.0410PSF
• Device Lot Number: 2241247
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2023
• Initial Report FDA Received Date: 11/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/03/2023
• 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: 73 YR
• Patient Sex: Male
• Patient Weight: 70 KG