MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE 02.12.T3I4R TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 R; KNEE TIBIAL TRAY FIXED CEMENTED

Model Number	02.12.T3I4R
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 14 february 2023: lot 2105438: (b)(4) items manufactured and released on 27-jul-2021.Expiration date: 2026-jul-12.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Other devices involved: gmk-sphere 02.12.0414fr tibial insert fixed sphere flex size 4/14 mm r (k121416) lot 1902504: (b)(4) items manufactured and released on 03-jun-2019.Expiration date: 2024-may-12.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Gmk-sphere 02.12.0004r femoral component sphere cemented size 4 r (k1214169) lot 2110993: (b)(4) items manufactured and released on 05-oct-2021.Expiration date: 2026-sep-22.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Gmk-sphere 02.12.0414crr tibial insert fixed sphere cr size 4/14 mm r (k181635) lot 1902542: (b)(4) items manufactured and released on 17-jun-2019.Expiration date: 2024-jun-02.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation performed by medical affairs director: early infection after primary tka caused bone resorption and ligament laxity.In these conditions, the original prosthesis was not suited any longer and needed replacement with a more constrained design.Infections are an unfortunate adverse event that may happen after total joint arthroplasty, widely described in literature, and it should be regarded as the root cause of this adverse event.There is no reason to suspect a faulty device at the origin of this problem.Analysis performed by r&d manager: revision surgery after 1 years from primary implantation for loosening of the implant due to bone resorption and ligament laxity, caused by infection.A more constrained device has been implanted.From the picture of the explanted devices, some residual cement can be identified on the internal surface of the femoral component and tibial tray, which suggests an original good fixation to the bone.Infection is an unfortunate adverse event that may happen after tka, that should be considered as root cause of adverse event.According to the pictures at hand, there is no reason to suspect that the root cause of the event is related to a faulty device.
Event or Problem Description
The patient had primary surgery on (b)(6) 2022.On (b)(6) 2022 the liner was revised due to infection (02.12.0414fr lot.1902504 removed and cr 02.12.0414crr lot.1902542 implanted).On (b)(6) 2023 all components were revised and hinge system implanted.The infection was already healed, however, the knee was unstable (ligament laxity) due to bone quality because the infection caused bone resorption.

• Brand Name: GMK-SPHERE 02.12.T3I4R TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 R
• 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: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 16512787
• Report Number: 3005180920-2023-00135
• Device Sequence Number: 12341330
• Product Code: JWH
• UDI-Device Identifier: 07630030827143
• UDI-Public: 07630030827143
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 03/09/2023

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: 07/12/2026
• Device Model Number: 02.12.T3I4R
• Device Catalogue Number: 02.12.T3I4R
• Device Lot Number: 2105438
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2023
• Initial Report FDA Received Date: 03/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/27/2021
• 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: 63 YR
• Patient Sex: Female
• Patient Weight: 63 KG