MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 1 R

Catalog Number	02.07.1201R
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 09 july 2018; lot 166833: (b)(4) items manufactured and released on 18 january 2017.Expiration date:2022-01-04; 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.
Event or Problem Description
Revision surgery performed due to tibial tray loosening, 9 months after surgery.
Additional Manufacturer Narrative
Patient match planning review performed on 26 july 2018 by patient match department our analysis of the myknee process of this case found no deviations from the standard procedures.Each step has been performed correctly.Clinical evaluation perfomed by medical affairs director one year after primary tka the tibial tray got loose.No xrays are available for analysis.We could not detrmine if the problem arose from detachment of the tray from the cement layer or if it was a loosening of cement mantle from bone, or both.We regret not being able to proceed further with the investigation in this case.

• Brand Name: GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 1 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: 7677481
• Report Number: 3005180920-2018-00492
• Device Sequence Number: 1370372
• Product Code: JWH
• UDI-Device Identifier: 07630030819858
• UDI-Public: 07630030819858
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 08/24/2018

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: 01/04/2022
• Device Catalogue Number: 02.07.1201R
• Device Lot Number: 166833
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2018
• Supplement Date Received by Manufacturer: 06/11/2018
• Initial Report FDA Received Date: 07/11/2018
• Supplement Report FDA Received Date: 08/24/2018
• 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: 58 YR