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

Catalog Number	01.18.417
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed by medacta regulatory affairs department on 25 september 2020: lot 179952: 113 items manufactured and released on (b)(6) 2018.Expiration date: 2023-05-13.No anomalies found related to the problem.To date, 48 items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
The patient came in reporting pain due to a subsided stem after 1 year and 5 months from the primary surgery.The surgeon revised the stem, head, and liner.During the primary hip surgery, while the surgeon was inserting the stem, the patient's greater trochanter fractured.The surgeon cabled the fracture.

• Brand Name: STEM: AMISTEM P LAT STEM SIZE 7
• Common Device Name: HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10668668
• Report Number: 3005180920-2020-00706
• Device Sequence Number: 437159
• Product Code: LZO
• UDI-Device Identifier: 07630040720168
• UDI-Public: 07630040720168
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K173794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/13/2020

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2020
• Initial Report FDA Received Date: 10/13/2020
• 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