MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 6 L; FEMORAL COMPONENT CEMENTED

Catalog Number	02.12.0006L
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 23 october 2018.Lot 152870: (b)(4) items manufactured and released on 11 september 2015.Expiration date: 2020-07-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Gmk-sphere tibial tray fixed cemented size 5 l reference 02.07.1205l (k090988).Lot 155594: (b)(4) items manufactured and released on 28 december 2015.Expiration date: 2020-12-07.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any similar reported event.Preliminary investigation based on the picture of the explanted components performed on october 24, 2018 by r&d product manager: revision surgery after 2 years and a half from primary implantation for pain.During revision surgery, the surgeon determined that no adhesion occurred between the cement and the components.From inspection of the pictures enclosed, no traces of residual cement can be seen on the tibial tray and on the femoral component.All the cement remained adherent to the bone.Absence or lack of cement on explanted components is usual to be seen even if the cause of revision is not loosening or mobilization.Therefore this is not an evidence of lack of adhesion between the cement and the implant due to faulty devices.Furthermore any non-conformity can be revealed in the distal surface of the component that could have contributed to the event.Poor cement inter-digitation on the implant surface are of various origin; they could be related to the cement and cementation procedure or mobilization of the implant during curing.Patient match department analysed the case and on october 05, 2018.They reported our analysis of the myknee process of this case found no deviations from the standard procedures.Each step has been performed correctly.
Event or Problem Description
The patient came in complaining of pain and stiffness.The surgeon opened the patient and noticed that the cement did not adhere to the implants.The type of cement used is palacos r.They were able to pop off the femur and tibia components with essentially no effort.None of the cement stuck to the components.The surgeon removed the femur, insert and tibia and replaced it with another company's product.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 6 L
• Common Device Name: FEMORAL COMPONENT CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7999370
• Report Number: 3005180920-2018-00819
• Device Sequence Number: 1311175
• Product Code: JWH
• UDI-Device Identifier: 07630030825873
• UDI-Public: 07630030825873
• 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: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/24/2018

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: 07/31/2020
• Device Catalogue Number: 02.12.0006L
• Device Lot Number: 152870
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2018
• Initial Report FDA Received Date: 10/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR