MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY FEMUR CEMENTED STD SIZE 4NARROW / LEFT

Catalog Number	02.07.2014L
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 03 april 2018 lot 141436: (b)(4) items manufactured and released on 30 april 2014.Expiration date: 2019-03-31.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any similar reported event.Tibial insert uc fixed size 3 / 17 mm reference (b)(4) (k090988): lot 147974: (b)(4) items manufactured and released on 13 february 2015.Expiration date: 2019-12-31.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.Tibial tray fixed cemented size 3 l reference (b)(4) (k090988) lot 144885: (b)(4) items manufactured and released on 17 september 2014.Expiration date: 2019-08-31.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.
Event or Problem Description
About 2 years and 4 months after primary the surgeon revised the patient for a knee infection (staphylococcus epidermidis).The surgery was completed successfully.
Additional Manufacturer Narrative
On 07 august 2018 we were informed that the spacer was removed on (b)(6) 2018 and permanent implants were put in.

• Brand Name: GMK-PRIMARY FEMUR CEMENTED STD SIZE 4NARROW / LEFT
• Common Device Name: FEMUR CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7395353
• Report Number: 3005180920-2018-00201
• Device Sequence Number: 69575
• Product Code: JWH
• UDI-Device Identifier: 07630030820359
• UDI-Public: 07630030820359
• 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: 2014
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2018

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: 03/31/2019
• Device Catalogue Number: 02.07.2014L
• Device Lot Number: 141436
• 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: 03/05/2018
• Supplement Date Received by Manufacturer: 03/05/2018
• Initial Report FDA Received Date: 04/04/2018
• Supplement Report FDA Received Date: 09/06/2018
• 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
• Patient Age: 67 YR