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

Catalog Number	02.07.2204L
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 20 may 2019: lot 167406: (b)(4) items manufactured and released on 08-feb-2017.Expiration date: 2022-01-29.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event additional implant involved in the event: gmk-primary 02.07.0410 apps full-pe ps tibial component size 4/10 (k131310), lot 174589: (b)(4) items manufactured and released on 28-jul-2017.Expiration date: 2022-07-12.No anomalies found related to the problem.To date, all the items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
Revision surgery performed due to infection, 4 months after primary.The surgeon revised the femoral and the full-pe ps tibial component.The surgery was completed successfully, the pathogen is unknown.

• Brand Name: GMK-PRIMARY FEMUR PS CEMENTED SIZE 4
• Common Device Name: KNEE FEMUR PS CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8631631
• Report Number: 3005180920-2019-00398
• Device Sequence Number: 2016710
• 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: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/22/2019

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: 01/29/2022
• Device Catalogue Number: 02.07.2204L
• Device Lot Number: 167406
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2019
• Initial Report FDA Received Date: 05/22/2019
• 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