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

Catalog Number	02.12.T3I4R
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/25/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 14 november 2018: lot 163351: (b)(4) items manufactured and released on 21 june 2016 expiration date: 2021-06-06.No anomalies found related to the issue.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Visual inspection of the explanted tibia tray and pe inlay performed by r&d product manager on november 15, 2018 revision surgery after 2 years from primary surgery for pain and suspected loosening of the tibia component.No traces of residual cement can be seen on the tibial tray.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.
Event or Problem Description
About 2 years after primary the surgeon revised the patient for tibial plateau loosening.The surgeon swapped successfully the tibial components.The surgery was completed successfully.

• Brand Name: GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 R
• 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: 8073323
• Report Number: 3005180920-2018-00895
• Device Sequence Number: 2262301
• Product Code: JWH
• UDI-Device Identifier: 07630030827143
• UDI-Public: 07630030827143
• 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: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/15/2018

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: 06/06/2021
• Device Catalogue Number: 02.12.T3I4R
• Device Lot Number: 163351
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2018
• Initial Report FDA Received Date: 11/15/2018
• 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: 78 YR