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

Catalog Number	01.39.409
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	02/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs manager: few weeks after cementless total hip arthroplasty, the patient reported pain due to a fracture in the calcar region.During rehabilitation period, a sudden movement on a weakened bone due to normal femoral preparation may favour the occurrence of early fracture.There is no reason to suspect a faulty device.Batch review performed on 12 march 2019: lot 180715: (b)(4) items manufactured and released on 23-apr-2018.Expiration date: 2023-04-12.No anomalies found related to the problem.To date, (b)(4) items of this lot have already been sold without any other similar event reported.
Event or Problem Description
On (b)(6) 2019 we were informed about a surgery planned for the next day due to patient feeling pain on 'touching his toes' during routine physiotherapy post-surgery.The primary surgery was done three weeks before.Investigation via ct scan showed a small fracture at the calcar.The surgeon did not think that the stem had subsided noticeably.He did not explant the stem and resolved the fracture with two cerclage wires, one above and one below the fracture.Primary implants in situ are size 9 lat+ masterloc stem, 54 versafit cup, liner e ceramic, 36-s ceramic head.

• Brand Name: STEM: MASTERLOC CEMENTLESS TI COATED LAT PLUS 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: 8417169
• Report Number: 3005180920-2019-00161
• Device Sequence Number: 1436427
• Product Code: LZO
• UDI-Device Identifier: 07630040715812
• UDI-Public: 07630040715812
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K173267
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/13/2019

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: 04/12/2023
• Device Catalogue Number: 01.39.409
• Device Lot Number: 180715
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2019
• Initial Report FDA Received Date: 03/13/2019
• 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
• Patient Age: 68 YR