MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE 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	Pain (1994)
Date of Event	10/04/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 05 october 2023 lot 2005698: (b)(4) items manufactured and released on 02-dec-2020.Expiration date: 2025-11-24.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Clinical evaluation performed by medical affairs department a re-intervention was conducted 2 years after the first implant of a cemented gmk sphere to resurface the patella and change the tibial inlay.Clinical information about the patient are not reported.During the surgery, the operator checked the stability of tibial and femoral components by "a little hammering" and these could be removed "very easily".In tre pre op x-ray, the implants do not appear radiologically loose.Not having the post operative x-ray (of first surgery) we can not assess the eventual migration of the components, even though they seem in the correct position.The pictures of the explants show the absence of cement on the backsurface, which could be indicator of some problem happened during cementation phase.With the information at hand, we have no reason to suspect a defective or malfunctioning device.Additional involved implant.Batch review performed on 05 october 2023 on gmk-sphere 02.12.0026r femoral component sphere cemented size 6+ r (k140826) lot.2004487 lot 2004487: (b)(4) items manufactured and released on 03-aug-2020.Expiration date: 2025-07-26.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.
Event or Problem Description
Revision surgery due to secondary patella resurfacing and inlay swap (as per standard procedure), at about 2 years 3 months from the primary.During intraoperative check of prosthesis fixation, after little hammering, femoral component cemented and tibial tray fixed cemented were easy to take out.No cement on backsurface.The surgeon revised all components to competitor's system and the surgery was completed successfully.

• Brand Name: GMK-SPHERE 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: 18054070
• Report Number: 3005180920-2023-00831
• Device Sequence Number: 14970957
• Product Code: JWH
• UDI-Device Identifier: 07630030819933
• UDI-Public: 07630030819933
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 11/02/2023

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: 11/24/2025
• Device Catalogue Number: 02.07.1205R
• Device Lot Number: 2005698
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2023
• Initial Report FDA Received Date: 11/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/02/2020
• 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 Age: 80 YR
• Patient Sex: Male