MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FEMUR CEMENTED STD SIZE 5NARROW / RIGHT

Catalog Number	02.07.2015R
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 06 march 2018 lot 150297: (b)(4) items manufactured and released on 15 april 2015.Expiration date: 2020-02-29 no anomalies found related to the problem.To date, all items of the same lot have been already sold without any similar reported event.Gmk-revision fixed tibial tray cemented size 4 r reference (b)(4) (k123721) lot 150591: (b)(4) items manufactured and released on 26 march 2015.Expiration date: 2020-02-29.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with a similar reported event.Gmk-revision tibial insert uc fixed size 4 / 17 mm reference (b)(4) (k090988) lot 130893: (b)(4) items manufactured and released on 11 april 2013.Expiration date: 2018-02-28 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.
Event or Problem Description
Two years after primary the surgeon revised the patient for a knee infection (b)(6) ((b)(6)).The surgeon revised successfully the patient swapping femur, tibia and liner.

• Brand Name: GMK-REVISION FEMUR CEMENTED STD SIZE 5NARROW / RIGHT
• Common Device Name: FEMUR CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7319831
• Report Number: 3005180920-2018-00125
• Device Sequence Number: 10790761
• Product Code: JWH
• UDI-Device Identifier: 07630030820380
• UDI-Public: 07630030820380
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K122232
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/07/2018

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: 02/29/2020
• Device Catalogue Number: 02.07.2015R
• Device Lot Number: 150297
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2018
• Initial Report FDA Received Date: 03/07/2018
• 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