MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM P AMISTEM-P STD STEM SIZE 1; CEMENTLESS STEM

Catalog Number	01.18.401
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	01/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 26 january 2021.Lot 2000047: (b)(4) items manufactured and released on 13-may-2020.Expiration date: 2025-05-03.No anomalies found related to the problem.To date, (b)(4) 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 periprosthetic fracture 3 months after the primary.The cause of the periprosthetic fracture is unknown.The surgeon cabled the fracture, revised the stem and head with competitor products, and revised the medacta liner with a medacta liner.The surgery was completed successfully.

• Brand Name: STEM: AMISTEM P AMISTEM-P STD STEM SIZE 1
• Common Device Name: CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11341873
• Report Number: 3005180920-2021-00122
• Device Sequence Number: 11599918
• Product Code: LZO
• UDI-Device Identifier: 07630040720007
• UDI-Public: 07630040720007
• 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: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/18/2021

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: 05/03/2025
• Device Catalogue Number: 01.18.401
• Device Lot Number: 2000047
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2021
• Initial Report FDA Received Date: 02/18/2021
• 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