MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE 02.07.1206R TIBIAL TRAY FIXED CEMENTED SIZE 6 R

Model Number 02.07.1206R

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Necrosis (1971); Pain (1994)

Event Date 04/01/2022

Event Type  Injury  

Event Description

Anterior pain described by the patient.Patella necrosis.No infection but loosening of the femoral and tibial components.At 4 years and 8 month after the primary surgery, the surgeon revised all the components and resurfaced the patella bone.The system was changed from gmk-sphere implants to gmk-hinge; that's the reason for an insert changing.

Manufacturer Narrative

Batch review performed on 8 april 2022.Lot 168526: (b)(4) items manufactured and released on 05-apr-2017.Expiration date: 2022-03-26.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event since 2018.Other device implanted: batch review performed on 8 april 2022.Gmk-sphere 02.12.0006r femoral component sphere cemented # 6 r (k121416) lot 168741: (b)(4) items manufactured and released on 22-mar-2017.Expiration date: 2022-mar-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 since 2018.

• Brand Name: GMK-SPHERE 02.07.1206R TIBIAL TRAY FIXED CEMENTED SIZE 6 R
• Type of Device: TIBIAL TRAY FIXED CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 14250758
• MDR Text Key: 290390107
• Report Number: 3005180920-2022-00313
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 07630030819957
• UDI-Public: 07630030819957
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K090988
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/26/2022
• Device Model Number: 02.07.1206R
• Device Catalogue Number: 02.07.1206R
• Device Lot Number: 168526
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/01/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/05/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 150 KG