MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK REVISION FIXED TIBIAL TRAY CEMENTED SIZE 2

Catalog Number	02.07.0682L
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	02/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 13 march 2018; lot 172153: (b)(4) items manufactured and released on 14 june 2017.Expiration date: 2022-05-28 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-revision fixed tibial insert sc size 2/23mm reference 02.07.0223scf (k103170): lot 145726: (b)(4) items manufactured and released on 27 october 2014.Expiration date: 2019-09-30 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-revision femur revision ps size2 l reference 02.07.2402l (k102437) lot 172147: (b)(4) items manufactured and released on 14 june 2017.Expiration date: 2022-05-23 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
On (b)(6) 2018 medacta has been informed by the sales agent that patient came in complaining of instability.Surgeon plans to remove implants and input another company's product.On (b)(6) 2018 we were informed that patient revision surgery has not been rescheduled yet, maybe it will be done in (b)(6) 2018.
Additional Manufacturer Narrative
The surgeon revised the patient on april 10th using competitor implants and cemented stems.He removed medacta ps femur and tibia with stems.

• Brand Name: GMK REVISION FIXED TIBIAL TRAY CEMENTED SIZE 2
• Common Device Name: FIXED TIBIAL TRAY CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7338217
• Report Number: 3005180920-2018-00136
• Device Sequence Number: 10937394
• Product Code: JWH
• UDI-Device Identifier: 07630030819346
• UDI-Public: 07630030819346
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K123721
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2018

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: 05/28/2022
• Device Catalogue Number: 02.07.0682L
• Device Lot Number: 172153
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/12/2018
• Supplement Date Received by Manufacturer: 02/12/2018
• Initial Report FDA Received Date: 03/14/2018
• Supplement Report FDA Received Date: 05/09/2018
• 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: 54 YR