MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MASTERLOC CEMENTLESS TI COATED LAT STEM SIZE 2; CEMENTLESS HIP STEM

Catalog Number	01.39.202
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	07/31/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 28 august 2018; lot 166777: (b)(4) items manufactured and released on 26 january 2017.Expiration date: 2022-01-10; 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 medical affairs (b)(4) on 24 august 2018; postoperative femoral fracture, few weeks after primary cementless tha.The fracture probably happened on a weakend bone due to normal intraoperative femoral preparation during walking re-education period of time.No reason to suspect that this event is due to a faulty device.
Event or Problem Description
The patient came in complaining of pain 21 days after primary surgery.The surgeon determined that the patient had a fractured femur.The surgeon determined that the stem was undersized in the primary.The surgeon revised the stem and head.The surgery was completed successfully.

• Brand Name: MASTERLOC CEMENTLESS TI COATED LAT STEM SIZE 2
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7832918
• Report Number: 3005180920-2018-00640
• Device Sequence Number: 19125412
• Product Code: LZO
• UDI-Device Identifier: 07630030885624
• UDI-Public: 07630030885624
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K160289
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/30/2018

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: 01/10/2022
• Device Catalogue Number: 01.39.202
• Device Lot Number: 166777
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2018
• Initial Report FDA Received Date: 08/30/2018
• 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
• Patient Age: 66 YR