MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H HA COATED LAT STEM SIZE 0; CEMENTLESS HIP STEM

Catalog Number	01.18.140
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	03/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 10 april 2018; lot 174367: (b)(4) items manufactured and released on 02 november 2017.Expiration date: 2022-10-25; 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.
Event or Problem Description
The patient alleged pain 9 days after primary: the femoral bone was found fractured spirally.Revision surgery scheduled on (b)(6) 2018.It will be fixed with a wire.No further information will be obtained because medacta system was not used for the revision surgery.

• Brand Name: AMISTEM H HA COATED LAT STEM SIZE 0
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7425015
• Report Number: 3005180920-2018-00233
• Device Sequence Number: 16542109
• Product Code: LZO
• UDI-Device Identifier: 07630030804168
• UDI-Public: 07630030804168
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K121011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/12/2018

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: 10/25/2022
• Device Catalogue Number: 01.18.140
• Device Lot Number: 174367
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2018
• Initial Report FDA Received Date: 04/12/2018
• 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
• Patient Age: 73 YR