MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MASTERLOC CEMENTLESS TI COATED LAT STEM SIZE 5; CEMNTLESS HIP STEM

Catalog Number	01.39.205
Health Effect - Clinical Code	Hip Fracture (2349)
Date of Event	03/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 03 april 2018; lot 163569: (b)(4) items manufactured and released on 02 september 2016 expiration date: 2021-08-22; 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 on 06 april 2018; periprosthetic fracture in an elderly lady few days after primary cementless tha.There is no report of a traumatic event, but this may well have happened during the initial reeducation days.It may also be the consequence of a hidden intraoperative fracture, which is a common adverse event that may happen during femoral preparation.With the information available, no final conclusion can be drawn, but there is no indication that the problem may be due to a faulty device.
Event or Problem Description
A patient had a peri-prosthetic fracture found through x-ray taken surgeon two days after primary.Surgeon revised the implant with quadra- r size#1 successfully.Cerclage applied.

• Brand Name: MASTERLOC CEMENTLESS TI COATED LAT STEM SIZE 5
• Common Device Name: CEMNTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7402529
• Report Number: 3005180920-2018-00214
• Device Sequence Number: 13634118
• Product Code: LZO
• UDI-Device Identifier: 07630030885655
• UDI-Public: 07630030885655
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 04/06/2018

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 Catalogue Number: 01.39.205
• Device Lot Number: 163569
• 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: 03/07/2018
• Initial Report FDA Received Date: 04/06/2018
• 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: 81 YR
• Patient Weight: 71