MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY FEMUR PS CEMENTED SIZE 6 L; CEMENTED FEMUR

Model Number	02.07.2206L
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 24 september 2018; lot 173696: (b)(4) items manufactured and released on 10 october 2017.Expiration date: 2022-09-26; no anomalies found related to the problem.To date, (b)(4) item of the same lot have been already sold.Gmk-primary reference 02.07.0610apps (k131310) full-pe ps tibial component size 6/10 ; lot 135913: (b)(4) items manufactured and released on 20 march 2014.Expiration date: 2019-02-28; 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
Revision surgery performed due to signs of infection 2 months after surgery (the pathogen results are not available).The surgeon washed out the knee and revised the femur and tibia.
Additional Manufacturer Narrative
On (b)(6) 2020: the patient had permanent hardware implanted and an antibiotic spacer removed.
Event or Problem Description
On (b)(6) 2020: the patient had permanent hardware implanted and an antibiotic spacer removed.

• Brand Name: GMK-PRIMARY FEMUR PS CEMENTED SIZE 6 L
• Common Device Name: CEMENTED FEMUR
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7905433
• Report Number: 3005180920-2018-00725
• Device Sequence Number: 1683731
• Product Code: JWH
• UDI-Device Identifier: 07630030820885
• UDI-Public: 07630030820885
• 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,Followup
• Report Date (Section B): 02/27/2020

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: 09/26/2022
• Device Model Number: 02.07.2206L
• Device Catalogue Number: 02.07.2206L
• Device Lot Number: 173696
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2018
• Supplement Date Received by Manufacturer: 08/28/2018
• Initial Report FDA Received Date: 09/25/2018
• Supplement Report FDA Received Date: 02/27/2020
• 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