MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM C CEMENTED STD STEM SIZE 0 LOT. 187511 OR 1903196

Model Number	01.18.150
Health Effect - Clinical Code	Hip Fracture (2349)
Date of Event	12/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 19 december 2019: lot 1903196: (b)(4) items manufactured and released on 05-sept-2019.Expiration date: 2024-08-21.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.Lot 187511: (b)(4) items manufactured and released on 23-nov-2018.Expiration date: 2023-11-13.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 department.Postoperative femoral fracture, 3 months after primary cemented tha in a (b)(6) woman.According to the report, the fracture is due to a traumatic event.No reason to suspect that this event is due to a faulty device.
Event or Problem Description
About 4 months after primary the patient twisted her leg at home causing a peri prosthetic femur fracture.The surgeon revised successfully the patient stem.

• Brand Name: STEM: AMISTEM C CEMENTED STD STEM SIZE 0 LOT. 187511 OR 1903196
• Common Device Name: AMISTEM C CEMENTED STD STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9568224
• Report Number: 3005180920-2019-01132
• Device Sequence Number: 374595
• Product Code: LZO
• UDI-Device Identifier: 07630030804250
• UDI-Public: 07630030804250
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 03/12/2020

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 Model Number: 01.18.150
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2019
• Supplement Date Received by Manufacturer: 12/13/2019
• Initial Report FDA Received Date: 01/09/2020
• Supplement Report FDA Received Date: 03/12/2020
• 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
• Patient Age: 74 YR