MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM C CEMENTED STD STEM SIZE 0; CEMENTED STEM

Catalog Number	01.18.150
Health Effect - Clinical Code	Hip Fracture (2349)
Date of Event	11/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 19 november 2019: lot 188420: 50 items manufactured and released on 29-nov-2018.Expiration date: 2023-11-21.No anomalies found related to the problem.To date, 27 items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medical affairs manager: revision surgery performed 3 weeks after primary surgery in a 75 year old woman.The reason of the revision is the progression of an intraoperative periprosthetic fracture treated during primary surgery that did not heal 3 weeks after surgery.In this case, there is no reason to suspect a malfunctioning device.
Event or Problem Description
The patient had a per-operative peri-prostetic fracture fixed with a screw during the primary surgery.The patient had a fracture 3 week post-operation and was revised about 1 month post primary.Stem and head revised successfully.

• Brand Name: STEM: AMISTEM C CEMENTED STD STEM SIZE 0
• Common Device Name: CEMENTED STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9393428
• Report Number: 3005180920-2019-01021
• Device Sequence Number: 11488898
• Product Code: LZO
• UDI-Device Identifier: 07630030804250
• UDI-Public: 07630030804250
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K103189
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/02/2019

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: 11/21/2023
• Device Catalogue Number: 01.18.150
• Device Lot Number: 188420
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2019
• Initial Report FDA Received Date: 12/02/2019
• 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: 75 YR
• Patient Weight: 60