MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM COLLARED STEM COLLARED HA COATED STD STEM SIZE 4; CEMENTLESS HIP STEM

Model Number	01.18.234
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	07/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 17 july 2020: lot 178479: (b)(4) items manufactured and released on 14-mar-2018.Expiration date: 2023-03-04.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
After the implantation of amistem-h stem, the surgeon discovered the femoral fracture in the xray.The surgeon fixed the fracture with 2 wires.Total surgery time was about 3 hours and 30 minutes.The surgeon expressed an opinion that he felt subsidence feeling after the implantation of the amistem-h stem.Amis approach.

• Brand Name: STEM: AMISTEM COLLARED STEM COLLARED HA COATED STD STEM SIZE 4
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10331332
• Report Number: 3005180920-2020-00472
• Device Sequence Number: 3162655
• Product Code: LZO
• UDI-Device Identifier: 07630030804595
• UDI-Public: 07630030804595
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/28/2020

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 Expiration Date: 03/04/2023
• Device Model Number: 01.18.234
• Device Catalogue Number: 01.18.234
• Device Lot Number: 178479
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2020
• Initial Report FDA Received Date: 07/28/2020
• 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: Other
• Patient Age: 84 YR
• Patient Weight: 43