MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE 02.07.1206L TIBIAL TRAY FIXED CEMENTED SIZE 6 L; KNEE TIBIAL TRAY FIXED CEMENTED

Model Number	02.07.1206L
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	03/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 22 march 2023: lot 2002938: (b)(4) items manufactured and released on 24-june-2020.Expiration date: 2025-06-15.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.Preliminary investigation performed by r&d manager: revision surgery of a gmk sphere implant after 2 years from primary implantation for loosening.From the picture of the explanted components, no anomalies can be noted.We can see that the cement remained adherent to the bone.Poor interdigitation between implants and cement can have variuos origins, most likely related to the cementation process or the cement itself.From investigation, there is no evidence that the event is related to faulty devices.Other devices involved: gmk-sphere 02.12.0026l femoral component sphere cemented size 6+ l (k140826) lot 2003221: (b)(4) items manufactured and released on 07-july-2020.Expiration date: 2025-06-25.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.Gmk-sphere 02.07.0036rp patella resurfacing size 4 (k113571) lot 2008651: (b)(4) items manufactured and released on 28-sep-2020.Expiration date: 2025-09-08.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
The patient came in reporting reported knee pain.The surgeon ordered a ct scan which appeared the components were loose.While performing the revision, it was confirmed that all three cemented components were loose (tibia, femur and patella).At about 2 years from primary the surgeon revised all components and the surgery was completed successfully.

• Brand Name: GMK-SPHERE 02.07.1206L TIBIAL TRAY FIXED CEMENTED SIZE 6 L
• Common Device Name: KNEE TIBIAL TRAY FIXED CEMENTED
• 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: 16768424
• Report Number: 3005180920-2023-00251
• Device Sequence Number: 16957055
• Product Code: JWH
• UDI-Device Identifier: 07630030819940
• UDI-Public: 07630030819940
• 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: 2021
• 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): 04/19/2023

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: 06/15/2025
• Device Model Number: 02.07.1206L
• Device Catalogue Number: 02.07.1206L
• Device Lot Number: 2002938
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2023
• Initial Report FDA Received Date: 04/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/24/2020
• 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 Sex: Unknown