MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FEMUR REVISION PS SIZE 3; KNEE REVISION FEMUR

Catalog Number	02.07.2403L
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 17 june 2019: lot 173068: (b)(4) items manufactured and released on 10 october 2017.Expiration date: 2022-09-17.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.Additional implants involved.Batch review performed on 17 june 2019: gmk-revision 02.07.0003 offset connector 3 mm (k102437), lot 179215: (b)(4) items manufactured and released on 08 april 2018.Expiration date: 2023-03-14.No anomalies found related to the issue; two devices of the same lot are involved in this case.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Gmk-revision 02.05.03dw femoral wedge distal size 3/8mm (k102437) lot 170615: (b)(4) items manufactured and released on 06 april 2017.Expiration date: 2022-03-26.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.Gmk-revision 02.05.03dw femoral wedge distal size 3/8mm (k102437) lot 173127: (b)(4) items manufactured and released on 31 july 2017.Expiration date: 2022-06-29.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.Gmk-revision 02.05.03pw femoral wedge posterior size 3/5mm (k102437) lot 179818: (b)(4) items manufactured and released on 03 april 2018.Expiration date: 2023-03-09.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.Gmk-revision 02.07.Fcl16105 extension stem - fluted ø 16 l 105 (k120790) lot 183206: (b)(4) items manufactured and released on 10 july 2018.Expiration date: 2023-06-25.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.Gmk-revision 02.07.0682l revision fixed tibial tray cemented size 2 (k123721) lot 184295: (b)(4) items manufactured and released on 18 july 2018.Expiration date: 2023-07-10.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.Gmk-revision 02.09.Ta210 tibial augmentation size 2/10mm (k130299) lot 177979: (b)(4) items manufactured and released on 13 december 2017.Expiration date: 2022-12-04.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.Gmk-revision 02.09.Ta210 tibial augmentation size 2/10mm (k130299) lot 168981: (b)(4) items manufactured and released on 16 march 2017.Expiration date: 2022-03-07.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.Revision cone 02.07.Cs20 centred 3dmetal tibial cone s h20 (k170149) lot 163587: (b)(4) items manufactured and released on 15 december 2016.Expiration date: 2021-11-24.No anomalies found related to the issue.To date, (b)(4) items of the same lot have been already sold with 1 similar reported event.Gmk-revision 02.07.Fcl11105 extension stem - fluted ø 11 l 105 (k120790) lot 170580: 15 items manufactured and released on 05 may 2017.Expiration date: 2022-04-25.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.Batch review for gmk-revision 02.07.0214scf fixed tibial insert sc size 2/14mm (k103170) lot 174954: (b)(4) items manufactured and released on 07 november 2017.Expiration date: 2022-10-19.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.Preliminary investigation performed by medacta knee r&d manager: revision surgery after 6 months from implantation for infection.Infection is a known possible adverse event following every surgery, including tka.Nothing relevant to the event can be noted looking at pictures of the explanted components.To date, there is no reason to suspect that the cause may be linked to the implanted devices.
Event or Problem Description
Revision surgery 6 months after primary surgery, due to infection.The pathogen is unknown.The surgeon explanted all implants and implanted an antibiotic spacer and the surgery was completed successfully.

• Brand Name: GMK-REVISION FEMUR REVISION PS SIZE 3
• Common Device Name: KNEE REVISION FEMUR
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8711713
• Report Number: 3005180920-2019-00476
• Device Sequence Number: 2473079
• Product Code: JWH
• UDI-Device Identifier: 07630030821400
• UDI-Public: 07630030821400
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K102437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/19/2019

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: 09/17/2022
• Device Catalogue Number: 02.07.2403L
• Device Lot Number: 173068
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2019
• Initial Report FDA Received Date: 06/19/2019
• 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