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

Catalog Number	02.07.2003R
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/29/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch reviews performed on 25 september 2017.Lot 141545: (b)(4) items manufactured and released on 06 may 2014.Expiration date: 2019-03-31.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 tibial tray fixed cemented size 3 right, code 02.07.1203r, lot.166063 (k090988) lot 166063: (b)(4) items manufactured and released on 25 january 2017.Expiration date: 2022-01-12.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 tibial insert uc fixed size 3 / 17 mm, code 02.07.0317fuc, lot.135575 (k090988) lot 135575: (b)(4) items manufactured and released on 20 january 2014.Expiration date: 2018-11-30.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.
Event or Problem Description
The patient came in due to signs of infection.The pathogen is unknown.On (b)(6) 2017 another surgeon removed the implants and implanted an antibiotic spacer.On (b)(6) 2017 the surgeon revised the spacer and implanted medacta hardware.The surgery was completed successfully.

• Brand Name: GMK-PRIMARY FEMUR CEMENTED SIZE 3 STD RIGHT
• Common Device Name: KNEE FEMORAL COMPONENT CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6893682
• Report Number: 3005180920-2017-00537
• Device Sequence Number: 117422
• Product Code: JWH
• UDI-Device Identifier: 07630030820205
• UDI-Public: 07630030820205
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/26/2017

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: 03/31/2019
• Device Catalogue Number: 02.07.2003R
• Device Lot Number: 141545
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/29/2017
• Initial Report FDA Received Date: 09/26/2017
• 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