MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 1 L; KNEE CEMENTED TIBIAL TRAY

Catalog Number	02.07.1201L
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
About 7 years and 8 months after the primary surgery, revision surgery has been performed due to tibial subsidence.
Additional Manufacturer Narrative
Batch review performed on 25 jan 2024 lot 151680: (b)(4) manufactured and released on 12-may-2015.Expiration date: 2020-mar-31.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation performed by medical affairs department: 8 years after primary cemented tka, the tibial plateau subsided medially and required revision.This is due to bone failure and it should not be regarded as a problem originated by the implant.No post-primary images were supplied, so the initial position and implantation parameters could not be evaluated.Visual inspection performed by r&d project manager from visual inspection of the component returned for analysis, we can't identify any anomalies that could have played a role in the event.Baseplate sinking is most likely related to factors such as worsening of patient's conditions, poor bone quality, undersizing, malrotation rather than related to the device.As note, we can see some scratches on the polished surface most likely caused during the handling of the baseplate after explantation.From visual inspection, there is no evidence that the event is related to a faulty device.

• Brand Name: GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 1 L
• 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: 18765773
• Report Number: 3005180920-2024-00039
• Device Sequence Number: 4387325
• Product Code: JWH
• UDI-Device Identifier: 07630030819841
• UDI-Public: 07630030819841
• 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: 2016
• Device Explanted Year: 2024
• 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): 02/23/2024

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: 03/31/2020
• Device Catalogue Number: 02.07.1201L
• Device Lot Number: 151680
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2024
• Initial Report FDA Received Date: 02/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2015
• 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: Female
• Patient Weight: 78 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White