MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FIXED TIBIAL TRAY CEMENTED SIZE 3 L

Catalog Number	02.07.0683L
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/31/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 8 august 2019: lot 163519: (b)(4) items manufactured and released on 26 july 2016.Expiration date: 2021-06-12.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.Additional implants involved in the event, batch review performed on 8 august 2019: gmk-revision 02.07.0005 offset connector 5 mm (k102437) lot.172194.Lot 172194: (b)(4) items manufactured and released on 21 september 2017.Expiration date: 2022-08-28.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with one similar reported event gmk-revision 02.07.Fcl14105 extension stem - fluted ø 14 l 105 (k120790) lot.162542.Lot 162542: (b)(4) items manufactured and released on 26 august 2016.Expiration date: 2021-07-27.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 02.07.0310psf tibial insert ps fixed # 3/10mm (k090988) lot.167467.Lot 167467: (b)(4) items manufactured and released on 10 february 2017.Expiration date: 2022-01-22.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 02.09.Ta305 tibial augmentation # 3/5mm (k130299) lot.155947.Lot 155947: (b)(4) items manufactured and released on 29 december 2015.Expiration date: 2020-11-21.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 02.07.Cs20 cono tibiale 3d metal centrato s h20 (k170149) lot.163587.Lot 163587: (b)(4) items manufactured and released on 15 december 2016.Expiration date: 2021-11-24.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with two similar reported event.
Event or Problem Description
On (b)(4) 2019 we received the information of a revision surgery, that was then performed on (b)(6) 2019, due to signs of an infection (the pathogen is unknown).The surgeon removed all implants from the patient and implanted an antibiotic spacer successfully.

• Brand Name: GMK-REVISION FIXED TIBIAL TRAY CEMENTED SIZE 3 L
• Common Device Name: FIXED TIBIAL TRAY CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8945082
• Report Number: 3005180920-2019-00713
• Device Sequence Number: 11479055
• Product Code: JWH
• UDI-Device Identifier: 07630030819360
• UDI-Public: 07630030819360
• 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: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/29/2019

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: 06/12/2021
• Device Catalogue Number: 02.07.0683L
• Device Lot Number: 163519
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2019
• Initial Report FDA Received Date: 08/29/2019
• 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