MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE FEMORAL COMPONENT SIZE 5 R; CONSTRAINED FEMORAL COMPONENT

Model Number	02.09.2605R
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	03/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 06 march 2020.Lot 164807: (b)(4) items manufactured and released on 07-sep-2016.Expiration date: 2021-08-18.No anomalies found related to the problem.To date, 7 items of the same lot have been already sold without any other similar reported event.Clinical evaluation: 3 years after a difficult revision surgery in a severe valgus knee with extremely poor bone stock, a bone fracture occurred in the metaphyseal femur.Given the delicate situation of the bone stock of this patient, we see no reason to think that this may have been caused by a defective device.
Event or Problem Description
The patient came in reporting pain after feeling a pop in his knee.The surgeon determined that the patient's femur had broken 2 years and 9 months after primary.There is no revision scheduled at this time.We don't know if revision surgery will be performed.

• Brand Name: GMK-HINGE FEMORAL COMPONENT SIZE 5 R
• Common Device Name: CONSTRAINED FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874, CHE; SZ 6874, CHE
• MDR Report Key: 9909608
• Report Number: 3005180920-2020-00200
• Device Sequence Number: 19024221
• Product Code: KRO
• UDI-Device Identifier: 07630030825484
• UDI-Public: 07630030825484
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K130299
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/01/2020

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: No Information
• Device Expiration Date: 08/18/2021
• Device Model Number: 02.09.2605R
• Device Catalogue Number: 02.09.2605R
• Device Lot Number: 164807
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2020
• Initial Report FDA Received Date: 04/01/2020
• 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: Other