MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE 02.07.1203L TIBIAL TRAY FIXED CEMENTED SIZE 3 L; KNEE TIBIAL TRAY FIXED CEMENTED

Catalog Number	02.07.1203L
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/26/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 3 months after the primary, the patient reported that was not able to walk properly.From the x-rays it was noticed a subsidence of the tibial tray, leaving to a varus condition.The revision was successfully completed by implanting a revision tibial tray of the same size along with a stem and tibial augment in the medial side.
Additional Manufacturer Narrative
Batch review performed on 02-nov-2023 lot 2202599: 24 items manufactured and released on 15-jun-2022.Expiration date: 2027-06-02.No anomalies found related to the problem.To date, 22 items of the same lot have been sold with no similar reported case during the period of review.Clinical evaluation performed by medical affairs department: a revision surgery was conducted/performed 3 months after the first implant of a gmk sphere (with tibal component cemented).The patient complained of walking problems, so she underwent an x ray check which showed a mobilization of the tibial tray with a medial subsidence.From the available images the tibial component appears slightly lateralized: this, along with other possible elements (poor bone quality, overload of the knee, etc.) may have led to the failure.Among these causes, the implant-cement debonding can also be counted, as little or no cement remained attached to the explanted baseplate: this could be influenced by several variables during the cementation process such as temperature (of the implant and of the room), time of insertion, presence of liquids and other possibilities not related to the implant.For these reasons, we see no reason to think that the prosthetic implant was defective.Visual inspection performed by r&d manager: revision surgery after 3 months after priamry of a gmk sphere implant due to tibia subsidence on the medial side.From visual inspection of the explanted baseplate sent back for investigation, we can't identify any anomalies or defects.From x-rays images, the component seems to be slightly lateralized with lack of coverage of the cortical bone on the medial side.This could have been the cause of the event together with poor bone quality or for a traumatic event / overload that may have occurred.From visual inspection, there is no reason to think that the event is related to a faulty device.

• Brand Name: GMK-SPHERE 02.07.1203L TIBIAL TRAY FIXED CEMENTED SIZE 3 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: 18204618
• Report Number: 3005180920-2023-00908
• Device Sequence Number: 17704184
• Product Code: JWH
• UDI-Device Identifier: 07630030819889
• UDI-Public: 07630030819889
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/24/2023

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: 02.07.1203L
• Device Lot Number: 2202599
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2023
• Initial Report FDA Received Date: 11/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2022
• 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: 81 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White