MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FEMUR REVISION PS SIZE 2 L; KNEE REVISION FEMORAL COMPONENT CEMENTED

Model Number	02.07.2402L
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/06/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 09 april 2022.Lot 113749: (b)(4) items manufactured and released on 17-jan-2012.Expiration date: 2016-12-31.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event on the same lot since 2018.Clinical evaluation performed by medical affairs department.At 6 years after revision tka, the femoral component mobilizes and needs replacement.The bone of this patient looks rather weak, the cortices are thin and the bone density in the metaphyseal distal femour appears to be low; this may due to the age of the lady patient.We see no reason to suspect a faulty device at the origin of this problem.
Event or Problem Description
At 5 years 8 months after the primary, revision surgery following the loosening of the femoral component.The surgeon revised successfully the femoral component and the inlay.

• Brand Name: GMK-REVISION FEMUR REVISION PS SIZE 2 L
• Common Device Name: KNEE REVISION FEMORAL COMPONENT CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 14547141
• Report Number: 3005180920-2022-00425
• Device Sequence Number: 6774660
• Product Code: JWH
• UDI-Device Identifier: 07630030821387
• UDI-Public: 07630030821387
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K102437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2022
• 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): 05/31/2022

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: 12/31/2016
• Device Model Number: 02.07.2402L
• Device Catalogue Number: 02.07.2402L
• Device Lot Number: 113749
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2022
• Initial Report FDA Received Date: 05/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/17/2012
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White