MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY FEMUR PS CEMENTED SIZE 4 LEFT; CEMENTED KNEE FEMORAL COMPONENT

Catalog Number	02.07.2204L
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/24/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch reviews performed on (b)(6) 2017.Lot 143728: (b)(4) items manufactured and released on (b)(6) 2014.Expiration date: 2019-07-31.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 full-pe ps tibial component size 4/10, code (b)(4) apps, lot.157694 (k131310); (b)(4) items manufactured and released on (b)(6) 2016.Expiration date: 2021-03-29.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 enterococcus.The surgeon washed out the knee and swapped the tibial component and the femur.The surgery was completed successfully.X-rays and explants are not available.

• Brand Name: GMK-PRIMARY FEMUR PS CEMENTED SIZE 4 LEFT
• Common Device Name: CEMENTED KNEE FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6812709
• Report Number: 3005180920-2017-00466
• Device Sequence Number: 1772016
• Product Code: JWH
• UDI-Device Identifier: 07630030820847
• UDI-Public: 07630030820847
• 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): 08/23/2017

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: 07/31/2019
• Device Catalogue Number: 02.07.2204L
• Device Lot Number: 143728
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/24/2017
• Initial Report FDA Received Date: 08/23/2017
• 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