MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM C CEMENTED STD STEM SIZE 2; CEMENTED STEM

Catalog Number	01.18.152
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994)
Date of Event	11/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 21 december 2018.Lot 163848: (b)(4) items manufactured and released on 26 july 2016.Expiration date: 2021-05-11.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medical affairs director on december 20, 2018.Revision surgery due to femoral fracture occurred 2 years after primary total hip arthroplasty.The fracture occurred during activities of daily living.No information on patient age and general health status is available.No conclusion can be drawn, but there is no reason to suspect a faulty device.
Event or Problem Description
The patient came in (1 year and 11 months after primary surgery) complaining of pain caused by a periprosthetic femur fracture, no trauma reported.The surgeon revised the head, stem and liner.

• Brand Name: AMISTEM C CEMENTED STD STEM SIZE 2
• Common Device Name: CEMENTED STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8199390
• Report Number: 3005180920-2018-01038
• Device Sequence Number: 1658335
• Product Code: LZO
• UDI-Device Identifier: 07630030804274
• UDI-Public: 07630030804274
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K103189
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/27/2018

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: 05/11/2021
• Device Catalogue Number: 01.18.152
• Device Lot Number: 163848
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2018
• Initial Report FDA Received Date: 12/27/2018
• 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