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	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/31/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 18 september 2018; lot 179634: (b)(4) items manufactured and released on 20 march 2018.Expiration date: 2023-03-08; 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.Clinical evaluation performed by medical affairs (b)(4) on 21 september 2018; tibial component revision surgery occurred 3 months after primary cemented total knee arthroplasty in a (b)(6) year old woman.Tibial baseplate looks anteriorly subsided and radiolucent lines at the implant-cement interface are visible in the x-rays provided.Such an early and extensive failure of tibial bone support is very rare and hardly understandable.The implant looks perfectly positioned after index surgery.There is no comment in the report about traumatic events or possibilities of infection.However, this is a failure of bone support, and therefore there is no reason to suspect a faulty device.
Event or Problem Description
We were informed on 23 august 2018 that a revision surgery is necessary due to suspicion loosening tibial plateau.The revision performed on (b)(6) 2018.
Additional Manufacturer Narrative
Visual inspection performed by r&d product manager on (b)(6) 2018: revision surgery after 3 months year from primary implantation for loosening of the tibial component.Visual inspection of the returned tibia tray and tibial insert.No traces of residual cement can be seen on the distal surface of the explanted tibial baseplate.This is something usual to be seen on explanted components even if the cause of revision is not instability, loosening or mobilization.Therefore, lack of cement on the distal surface is not an evidence of lack of adhesion between the cement and the implant.Furthermore, surface finishing of the implant seems to be in compliance with specifications required.Loosening could be linked to several factors that are not implant related, such as failure of cement or of the cementation process.Also the fall of the patient could have played a role, but this event has not been confirmed yet.

• 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, switzerland 6874 ; SZ 6874
• MDR Report Key: 7897539
• Report Number: 3005180920-2018-00713
• Device Sequence Number: 1707466
• Product Code: JWH
• UDI-Device Identifier: 07630030827136
• UDI-Public: 07630030827136
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2018

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: 03/08/2023
• Device Catalogue Number: 02.12.T3I4L
• Device Lot Number: 179634
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2018
• Supplement Date Received by Manufacturer: 08/23/2018
• Initial Report FDA Received Date: 09/21/2018
• Supplement 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: 60 YR
• Patient Weight: 70