MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FEMUR REVISION PS 3 R

Model Number	02.07.2403R
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed by regulatory affairs department on 3 june 2020: lot 177643: (b)(4) items manufactured and released on 2-mar-2016.Expiration date: 2023-02-18.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Lot 162505: (b)(4) items manufactured and released on 16-jun-2016.Expiration date: 2021-05-22.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Lot 187393: (b)(4) items manufactured and released on 5-dec-2018.Expiration date: 2023-11-21.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Lot 186276: (b)(4) items manufactured and released on 2 october 2018.Expiration date: 2023-09-18.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Lot 168978: (b)(4) items manufactured and released on 20 march 2017.Expiration date: 2022-03-06.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Lot 182069: (b)(4) items manufactured and released on 9 may 2018.Expiration date: 2023-04-29.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Lot 184306: (b)(4) items manufactured and released on 31 july 2018.Expiration date: 2023-07-17.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Lot 187623: (b)(4) items manufactured and released on 12 december 2018.Expiration date: 2023-11-28.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.
Event or Problem Description
The patient came in 1 year and 3 months after the primary surgery reporting pain due to a failed extensor mechanism which was caused due to tissue degeneration.The surgeon revised all implants and converted them to a gmk hinge knee.The surgery was completed successfully.

• Brand Name: GMK-REVISION FEMUR REVISION PS 3 R
• Common Device Name: FEMUR REVISION
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874, CHE; SZ 6874, CHE
• MDR Report Key: 10118170
• Report Number: 3005180920-2020-00305
• Device Sequence Number: 16673289
• Product Code: JWH
• UDI-Device Identifier: 07630030821417
• UDI-Public: 07630030821417
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K102437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/04/2020

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: No Information
• Device Expiration Date: 02/18/2023
• Device Model Number: 02.07.2403R
• Device Catalogue Number: 02.07.2403R
• Device Lot Number: 177643
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2020
• Initial Report FDA Received Date: 06/04/2020
• 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