MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY FEMUR PS CEMENTED SIZE 5; FEMUR CEMENTED

Catalog Number	02.07.2205L
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 13 november 2018.Lot 171119: (b)(4) items manufactured and released on 28 june 2017.Expiration date: 2022-06-13 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 4/14 reference 02.07.0414apps.Lot 135907: (b)(4) items manufactured and released on 04 march 2014.Expiration date: 2019-01-31.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 patella resurfacing size 2 reference 02.07.0034rp.Lot 176700: (b)(4) items manufactured and released on 01 march 2018.Expiration date: 2023-02-14.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 infection 3 months after the primary.The current pathogen is unknown.All hardware was revised.

• Brand Name: GMK-PRIMARY FEMUR PS CEMENTED SIZE 5
• Common Device Name: FEMUR CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8069020
• Report Number: 3005180920-2018-00893
• Device Sequence Number: 2190657
• Product Code: JWH
• UDI-Device Identifier: 07630030820861
• UDI-Public: 07630030820861
• 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: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/14/2018

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: 06/13/2022
• Device Catalogue Number: 02.07.2205L
• Device Lot Number: 171119
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2018
• Initial Report FDA Received Date: 11/14/2018
• 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