MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY FEMUR CEMENTED STD SIZE 3NARROW / RIGHT; CEMENTED FEMORAL COMPONENT

Model Number	02.07.2013R
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 11 june 2021: lot 1906854: (b)(4) items manufactured and released on 15-oct-2019.Expiration date: 2024-oct-05.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold.No other similar event has been reported for this lot.Tibial tray not distributed in usa.
Event or Problem Description
Revision surgery performed due to tibial tray and femoral component mobilization 2 months after the primary surgery.All implants were revised.

• Brand Name: GMK-PRIMARY FEMUR CEMENTED STD SIZE 3NARROW / RIGHT
• Common Device Name: CEMENTED FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12090818
• Report Number: 3005180920-2021-00538
• Device Sequence Number: 17125068
• Product Code: JWH
• UDI-Device Identifier: 07630030820342
• UDI-Public: 07630030820342
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K122232
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/30/2021

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: 10/05/2024
• Device Model Number: 02.07.2013R
• Device Catalogue Number: 02.07.2013R
• Device Lot Number: 1906854
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2021
• Initial Report FDA Received Date: 06/30/2021
• 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: 73 YR
• Patient Weight: 83