MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM H HA COATED STD STEM SIZE 7; CEMENTLESS HIP STEM

Catalog Number	01.18.137
Health Effect - Clinical Code	Hip Fracture (2349)
Date of Event	01/10/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs director on (b)(6) 2018: intraoperative femoral fracture during primary cementless tha.This is a possible, literature-described adverse event, which is normally due to mechanical reasons, often because of a peculiar anatomy.There is no reason to suspect a faulty device as responsible of the adverse event.Batch review performed on (b)(6) 2018: lot 122930b: 3 items manufactured and released on 28 july 2017.Expiration date: 2022-08-17.No anomalies found related to the issue.To date, this is the only item of the same lot already sold.
Event or Problem Description
During the stem positioning a femur fracture was generated.The surgeon completed successfully the surgery performing intraoperatively a bone cerclage.

• Brand Name: STEM: AMISTEM H HA COATED STD STEM SIZE 7
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7276203
• Report Number: 3005180920-2018-00052
• Device Sequence Number: 1276200
• Product Code: LZO
• UDI-Device Identifier: 07630030804137
• UDI-Public: 07630030804137
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/16/2018

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: 08/17/2022
• Device Catalogue Number: 01.18.137
• Device Lot Number: 122930B
• 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: 01/17/2018
• Initial Report FDA Received Date: 02/16/2018
• 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