MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2 L

Model Number	02.07.1202L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032)
Date of Event	01/30/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery at about 1 year and 8 months after primary for knee stiffness and patellofemoral pain.The surgeon revised all the devices successfully.
Additional Manufacturer Narrative
Batch review performed on 06 february 2023: lot 2102494: (b)(4) items manufactured and released on 04-may-2021.Expiration date: 2026-04-22.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.Visual inspection performed by r&d knee manager: from visual inspection no anomalies can be noted on the explanted devices that could have played a role in the event.No residual cement on the tibia baseplate and no residual bone can be noted on the internal surface of the femur intended to be in contact with the bone.This is not an evidence of lack of fixation; in fact, in the event description, loosening has not been reported.Yellow markings can be seen on the explanted tibial insert.This turning of the color into yellow in some portions of the uhmwpe components.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.Additional devices involved in the event, batch review performed on 06 february 2023: gmk-sphere 02.12.1002l femoral component sphere cementless size 2 l lot.1810121 (item not registered in usa).Lot 1810121: (b)(4) items manufactured and released on 23-apr-2019.Expiration date: 2024-04-08.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.Gmk-sphere 02.12.0210fl tibial insert fixed sphere flex size 2/10 mm l (k121416) lot.2010581 lot 2010581: (b)(4) items manufactured and released on 10-dec-2020.Expiration date: 2025-11-26.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.

• Brand Name: GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2 L
• Common Device Name: TIBIAL TRAY FIXED
• 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: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 16458789
• Report Number: 3005180920-2023-00103
• Device Sequence Number: 14067065
• Product Code: JWH
• UDI-Device Identifier: 07630030819865
• UDI-Public: 07630030819865
• 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: 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): 03/01/2023

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: 04/22/2026
• Device Model Number: 02.07.1202L
• Device Catalogue Number: 02.07.1202L
• Device Lot Number: 2102494
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2023
• Initial Report FDA Received Date: 03/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2021
• 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: 71 YR
• Patient Sex: Female
• Patient Weight: 50 KG