MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM P AMISTEM-P LAT STEM SIZE 7; CEMENTLESS HIP STEM

Catalog Number	01.18.417
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	04/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 29 apr 2019: lot 179952: (b)(4) items manufactured and released on 24-may-2018.Expiration date: 2023-05-13.No anomalies found related to the problem.To date, (b)(4) items of this same lot have been already sold without any other similar reported event.
Event or Problem Description
During the primary hip surgery and while inserting the stem, the patient's greater trochanter fractured.The surgeon cabled the fracture and there was a 5-minute delay in the case.The surgery was completed successfully.

• Brand Name: STEM: AMISTEM P AMISTEM-P LAT STEM SIZE 7
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8564991
• Report Number: 3005180920-2019-00337
• Device Sequence Number: 11500093
• Product Code: LZO
• UDI-Device Identifier: 07630040720168
• UDI-Public: 07630040720168
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K173794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/30/2019

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: 05/13/2023
• Device Catalogue Number: 01.18.417
• Device Lot Number: 179952
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2019
• Initial Report FDA Received Date: 04/30/2019
• 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