MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 L

Catalog Number	02.12.T3I4L
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	09/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 21 august 2019: lot 153116: 64 items manufactured and released on 12-jun-2015.Expiration date: 2020-04-30.No anomalies found related to the problem.To date, 63 items of the same lot have been already sold without any other similar reported event.Clinical evaluation performed by medical affairs director few weeks after primary cemented tka, the tibial component is found loose.Although no information is available, it is very likely that a problem has occurred during cementation of the component.No definite conclusion can be reached on this case at this time.Preliminary investigation performed by r&d knee manager.Revision surgery after 1 month from primary implantation for loosening of the tibia component.From the picture of the explanted implant, no residual cement can be identified on the distal surface of the tibia tray.Surface finishing of the tibia baseplate seems to be in compliance with the specifications required.Any other non-conformities can't be revealed on the implant that could have contributed to the event.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.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.From preliminary investigation there is no evidence that the event is related to a faulty device.
Event or Problem Description
The surgeon has notified that the tibial component of the patient is loose.Revision performed almost 1 month after primary.The surgery was completed successfully.We were informed about the event on august 20, the revision surgery has been performed on (b)(6).

• Brand Name: GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 L
• Common Device Name: TIBIAL TRAY FIXED CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9086484
• Report Number: 3005180920-2019-00769
• Device Sequence Number: 2614819
• Product Code: JWH
• UDI-Device Identifier: 07630030827136
• UDI-Public: 07630030827136
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/18/2019

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: 04/30/2020
• Device Catalogue Number: 02.12.T3I4L
• Device Lot Number: 153116
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2019
• Initial Report FDA Received Date: 09/19/2019
• 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: 75 YR
• Patient Weight: 90