MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 R; KNEE CEMENTED FEMORAL COMPONENT

Catalog Number	02.12.0005R
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	05/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 24 may 2024 lot 168738: (b)(4) items manufactured and released on 16-mar-2017.Expiration date: 2022-03-02.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.Preliminary analysis performed by r&d project manager from the analysis of the pictures of the explanted components, no anomalies can be noted on the implants.No residual cement can be identifed on the distal surface of tibial baseplate and on the internal surface of the femoral component.Poor interdigitation between cement and implant can be related to multiple factors, not implant related (such as cementation process, temperature, time, presence of fluids on the surfaces of cement interface) on the articular surfaces of the tibial insert, no signs of wear or delamination can be noted.There is no evidence to suspect that the event is related to a faulty device.Addiitonal involved implant batch review performed on 24 may 2024 on gmk-sphere 02.07.1204r tibial tray fixed cemented size 4 r (k090988) lot.170446 lot 170446: (b)(4) items manufactured and released on 06-apr-2017.Expiration date: 2022-03-27.No anomalies found related to the problem.To date, all the items of the same lot have been sold with no similar reported event during the period of review.
Event or Problem Description
Revision surgery at about 6 years and 10 months post primary due to tibial and femoral components loosening.No cement on found on the implant during the revision.The patient was instable and there was devices malalingnment.Gmk revision system implanted successfully.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 R
• Common Device Name: KNEE CEMENTED FEMORAL COMPONENT
• 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: 19527700
• Report Number: 3005180920-2024-00415
• Device Sequence Number: 7513080
• Product Code: JWH
• UDI-Device Identifier: 07630030825866
• UDI-Public: 07630030825866
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/13/2024

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: 03/02/2022
• Device Catalogue Number: 02.12.0005R
• Device Lot Number: 168738
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2024
• Initial Report FDA Received Date: 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/16/2017
• 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 Sex: Female