MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 L; KNEE CEMENTED TIBIAL TRAY

Catalog Number	02.07.1204L
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 30 august 2023: lot 2005039: (b)(4) items manufactured and released on 16-sep-2020.Expiration date: 2025-09-06.No anomalies found related to the problem.To date, all the items of the same lot have been sold without any similar reported event in the period of review.Visual inspection performed by r&d project manager: from visual inspection of the explanted components returned for investigation, no anomalies that could have played a role in the event can be noted.No residual cement can be noted on the tibial and femoral component.Uhmwpe tibial insert turned into yellow in some portions.This is something already experienced and deeply analyzed in medacta and this is something that affects only the external surfaces of the insert and not related to abnormal oxidation of the liner.From visual inspection, there is no evidence that the event is related to a faulty device.Clinical evaluation performed by medical affairs department: 3 years after primary tka, the tibial plateau has a significant medial subsidence, which compromised the proximal tibial bone.We cannot determine the causes for this adverse event, but there is no reason to suspect a faulty device.The postoperative radiograph shows that the contact between the tibial baseplate and the tibial bone was suboptimal, but we have no indication as to what led to this situation, and we cannot tell if this was relevant for the final outcome.
Event or Problem Description
Revision surgery at 2 years and 8 months post primary for tibial tray subsidence.

• Brand Name: GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 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: 17798744
• Report Number: 3005180920-2023-00726
• Device Sequence Number: 15210906
• Product Code: JWH
• UDI-Device Identifier: 07630030819902
• UDI-Public: 07630030819902
• 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: 2020
• 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): 09/22/2023

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: 09/06/2025
• Device Catalogue Number: 02.07.1204L
• Device Lot Number: 2005039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2023
• Initial Report FDA Received Date: 09/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2020
• 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: 75 YR
• Patient Sex: Male
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White