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

Model Number	02.07.2204L
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2020: lot 148524: 20 items manufactured and released on 9-mar-2015.Expiration date: 2020-01-31.No anomalies found related to the problem.To date, 18 items of the same lot have been already sold without any similar reported event since 2016.Other devices involved in the event.Gmk-primary 02.07.1204l tibial tray fixed cemented size 4 l lot.160575 (k090988).Batch review performed on (b)(6) 2020: lot 160575: 37 items manufactured and released on 23-mar-2016.Expiration date: 2021-01-09.No anomalies found related to the problem.To date, 36 items of the same lot have been already sold without any similar reported event.
Event or Problem Description
The patient came in for a post-op appointment after 4 years and 4 months after the primary surgery reporting pain, and x-rays were taken.Rabiolucencies were seen when observing the x-rays.During the revision surgery, it was observed that the femur and tibia were loose and there was no cement present on the implants.The surgeon revised the femur, insert and tibia and the surgery was completed successfully.

• Brand Name: GMK-PRIMARY FEMUR PS CEMENTED SIZE 4 L
• Common Device Name: FEMUR CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10928290
• Report Number: 3005180920-2020-00845
• Device Sequence Number: 13650841
• Product Code: JWH
• UDI-Device Identifier: 07630030820847
• UDI-Public: 07630030820847
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: 02.07.2204L
• Device Catalogue Number: 02.07.2204L
• Device Lot Number: 148524
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2020
• Initial Report FDA Received Date: 12/01/2020
• 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
• Patient Age: 55 YR