MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FEMUR REVISION PS SIZE 5 L; CEMENTED KNEE FEMUR

Catalog Number	02.07.2405L
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 21 august 2019: lot 173070: (b)(4) items manufactured and released on 26-sep-2017.Expiration date: 2022-09-07.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.Clinical evaluation performed by medacta medical affairs director: few months after revision tka the femoral component got loose and needed revision.The information supplied is not enough to detect any specific cause for this adverse event.
Event or Problem Description
The patient came in, 1 year and 5 months after primary surgery, complaining of pain caused by an aseptic loosening of the femoral component.The surgeon revised the femoral component, stem, and poly.The surgery was completed successfully.

• Brand Name: GMK-REVISION FEMUR REVISION PS SIZE 5 L
• Common Device Name: CEMENTED KNEE FEMUR
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8987629
• Report Number: 3005180920-2019-00754
• Device Sequence Number: 3169174
• Product Code: JWH
• UDI-Device Identifier: 07630030821448
• UDI-Public: 07630030821448
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K102437
• 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): 09/11/2019

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: 09/07/2022
• Device Catalogue Number: 02.07.2405L
• Device Lot Number: 173070
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2019
• Initial Report FDA Received Date: 09/11/2019
• 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