MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE FEMORAL COMPONENT SIZE 5 R

Catalog Number	02.09.2605R
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 16 august 2018.Lot 168960: (b)(4) items manufactured and released on 26 april 2017.Expiration date: 2022-03-23 no anomalies found related to the problem.To date, (b)(4) pieces of the same lot has been sold and no similar events have been reported on items of the same lot.Gmk-hinge fixed tibial tray size 5 r reference 02.09.4005r (k130299).Lot 167694: (b)(4) items manufactured and released on 19 january 2017.Expiration date: 2022-01-10 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-hinge fixed tibial insert # 5/12 mm reference 02.09.0512h (k130299).Lot 173990: (b)(4) items manufactured and released on 19 september 2017.Expiration date: 2022-08-27 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-hinge extension stem - fluted ø 22 l 105 reference 02.07.Fcl22105 (k120790).Lot 161797: (b)(4) items manufactured and released on 10 may 2016.Expiration date: 2021-04-25.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
The patient came in due to signs of infection 7 months after primary.The pathogen is unknown.The surgeon revised all hardware and implanted a spacer.The date in which the spacer was implanted is unknown.The surgeon implanted permanent hardware on (b)(6) 2018.

• Brand Name: GMK-HINGE FEMORAL COMPONENT SIZE 5 R
• Common Device Name: FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7788798
• Report Number: 3005180920-2018-00605
• Device Sequence Number: 16491703
• Product Code: KRO
• UDI-Device Identifier: 07630030825484
• UDI-Public: 07630030825484
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K130299
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/16/2018

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: 03/23/2022
• Device Catalogue Number: 02.09.2605R
• Device Lot Number: 168960
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2018
• Initial Report FDA Received Date: 08/16/2018
• 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