MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 5 R; KNEE CEMENTED TIBIAL TRAY

Catalog Number	02.07.1205R
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 10 october 2023.Lot 113791: (b)(4) items manufactured and released on 07-dec-2011.Expiration date: 2016-10-31.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event during the period of review.
Event or Problem Description
At about 11 years 6 months after the primary, revision surgery due to a loose cemented tibial tray fixed.The surgeon observed that the cobalt cement seemed to be the loosening factor.The surgeon revised all components to revision components and the surgery was completed successfully.

• Brand Name: GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 5 R
• Common Device Name: KNEE CEMENTED TIBIAL TRAY
• 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: 18020319
• Report Number: 3005180920-2023-00847
• Device Sequence Number: 12396578
• Product Code: JWH
• UDI-Device Identifier: 07630030819933
• UDI-Public: 07630030819933
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• 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): 10/27/2023

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 Expiration Date: 10/31/2016
• Device Catalogue Number: 02.07.1205R
• Device Lot Number: 113791
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2023
• Initial Report FDA Received Date: 10/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/07/2011
• 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: 75 YR
• Patient Sex: Male
• Patient Weight: 111 KG