MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MASTERLOC CEMENTLESS TI COATED LAT STEM SIZE 9; CEMENTLESS HIP STEM

Catalog Number	01.39.209
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	06/04/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed on (b)(6) 2018 by medical affairs director the history of this case is not well documented.Apparently, 4 months after cementless tha in a woman with very poor bone quality a femoral fracture took place, with no reported traumatic event.The radiograph supplied shows a fractured femur but also a cable-plating system whose appearance we cannot date.This type of devices is normally used to treat fractures over a femoral stem (when no screws can be inserted), but if that is what happened, the fracture must have repeated after the plating and cabling was done.In any case, we do not see any problem that may have been caused by a faulty tha implant.Batch review performed on (b)(6) 2018.Lot 170628: 15 items manufactured and released on (b)(6) 2017.Expiration date: (b)(6) 2022.No anomalies found related to the problem.To date, 11 items of the same lot have been already sold without any similar reported event.
Event or Problem Description
The patient had poor bone quality and fractured her femur 4 months after primary.There was no report of trauma.The surgeon revised the stem and head.The surgery was completed successfully.

• Brand Name: MASTERLOC CEMENTLESS TI COATED LAT STEM SIZE 9
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7662368
• Report Number: 3005180920-2018-00476
• Device Sequence Number: 2527500
• Product Code: LZO
• UDI-Device Identifier: 07630030885693
• UDI-Public: 07630030885693
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K151531
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/04/2018

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: 06/27/2022
• Device Catalogue Number: 01.39.209
• Device Lot Number: 170628
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2018
• Initial Report FDA Received Date: 07/04/2018
• 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