MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE 02.07.1204L TIBIAL TRAY FIXED CEMENTED SIZE 4 L; KNEE TIBIAL TRAY FIXED CEMENTED

Model Number	02.07.1204L
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 10 may 2023.Lot 176243: (b)(4) items manufactured and released on 10-jan-2018.Expiration date: 2022-dec-17.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.Visual inspection performed by r&d manager: revision surgery of a gmk sphere implant after 5 years from primary implantation due to tibia sinking/loosening.From visual inspection of the explanted components, we can't identify any anomalies relevant to the event.The lateral side of the tibial insert looks worn out only in the posterior part, so probably the positioning of the tibial component in terms of rotation was sub-optimal.We can note also the color of the tibial insert turned yellow in some portions: this is something that affects only the external surfaces of the insert and is 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: about 5 years after primary cemented tka, the tibia plateau tilts backward and requires revision surgery.From the images received, it seems that the bone gave way and was not able to sustain the baseplate any longer for unknown reasons.This case should be classified as aseptic loosening, which is a possible adverse event following tka, described in literature.Other devices involved: gmk-sphere 02.12.0417fl tibial insert fixed sphere flex size 4/17 mm l (k121416) lot 162287: (b)(4) items manufactured and released on 25-jul-2016.Expiration date: 2021-jun-23.No anomalies found related to the problem.To date, 7 items of the same lot have been sold with no similar reported event during the period of review.Gmk-sphere 02.12.0025l femoral component sphere cemented size 5+ l (k140826) lot 178022: (b)(4) items manufactured and released on 10-jan-2018.Expiration date: 2022-dec-27.No anomalies found related to the problem.To date, 66 items of the same lot have been sold with no similar reported event during the period of review.
Event or Problem Description
About 5 years after the primary surgery, revision surgery was performed due to malpositioning of the tibial tray (the tibia has tilted backward).Hinge system implanted.

• Brand Name: GMK-SPHERE 02.07.1204L TIBIAL TRAY FIXED CEMENTED SIZE 4 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: 16917740
• Report Number: 3005180920-2023-00338
• Device Sequence Number: 20566640
• 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: 2018
• 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): 05/12/2023

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: 12/17/2022
• Device Model Number: 02.07.1204L
• Device Catalogue Number: 02.07.1204L
• Device Lot Number: 176243
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2023
• Initial Report FDA Received Date: 05/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/10/2018
• 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: 76 YR
• Patient Sex: Male
• Patient Weight: 75 KG
• Patient Race: White