MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY FEMUR CEMENTED SIZE 3 NARROW / RIGHT; FEMORAL COMPONENT CEMENTED

Catalog Number	02.07.2013R
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/31/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 25 march 2019: lot 130872: (b)(4) items manufactured and released on 22-march-2013.Expiration date: 2018-02-28.No anomalies found related to the problem.To date, all the items of the same lot have been already sold without any similar reported event.Other devices were involved in the complaint: gmk-primary 02.07.1202r tibial tray fixed cemented size 2 r lot.130006 (k090988): (b)(4) items manufactured and released on 22-mar-2013.Expiration date: 2018-02-28.No anomalies found related to the problem.To date, all the items of the same lot have been already sold without any similar reported event.Gmk-primary 02.07.0214fuc tibial insert uc fixed size 2 / 14 mm lot.123064 (k090988): (b)(4) items manufactured and released on 12-nov-2012.Expiration date: 2017-09-30.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-primary 02.07.0034rp patella resurfacing size 2 lot.130248 (k090988): (b)(4) items manufactured and released on 13-mar-2013.Expiration date: 2018-02-28.No anomalies found related to the problem.To date, all the items of the same lot have been already sold without any similar reported event.
Event or Problem Description
Revision surgery after 5 years and 9 months from the primary due to signs of infection (the pathogen is unknown).The surgeon performed a washout, removed all implants and implanted an antibiotic spacer.The surgery was completed successfully.
Additional Manufacturer Narrative
The antibiotic spacer has been removed on may 31 and a permanent hardware has been implanted.
Event or Problem Description
On the (b)(6) 2019, 3 moths after the revision surgery the surgeon removed the spacer and implanted the definitive implants.

• Brand Name: GMK-PRIMARY FEMUR CEMENTED SIZE 3 NARROW / RIGHT
• Common Device Name: FEMORAL COMPONENT CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8455409
• Report Number: 3005180920-2019-00193
• Device Sequence Number: 3219089
• Product Code: JWH
• UDI-Device Identifier: 07630030820342
• UDI-Public: 07630030820342
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K122232
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2019

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: 02/28/2018
• Device Catalogue Number: 02.07.2013R
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2019
• Supplement Date Received by Manufacturer: 02/25/2019
• Initial Report FDA Received Date: 03/27/2019
• Supplement Report FDA Received Date: 06/28/2019
• 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