MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H HA COATED LAT STEM SIZE 2; CEMENTLESS HIP STEM

Catalog Number	01.18.142
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	05/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 05 june 2018; lot 170028: (b)(4) items manufactured and released on 16 june 2017.Expiration date: 2022-06-01 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
A few days after primary surgery, a fracture was noticed even if there was no sign of fracture immediately post op and no trauma reported as the reason for the fracture.The femur was cabled, but then the stem loosened and subsided.The stem and head were explanted.
Additional Manufacturer Narrative
Clinical evaluation performed on 08 june 2018 by medical affairs director: stem and head revision surgery in a (b)(6) woman treated for an immediate postoperative fracture following primary cementless tha.The initial position of the stem and cables cannot be assessed not having the post operative x-ray.This event may be due to undetected problems arisen during primary operation that may have weakened the bone which was later fractured by weight bearing and loads, but other unknown conditions may also play a role.We see no reason to suspect a faulty device.

• Brand Name: AMISTEM H HA COATED LAT STEM SIZE 2
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7578033
• Report Number: 3005180920-2018-00400
• Device Sequence Number: 2354902
• Product Code: LZO
• UDI-Device Identifier: 07630030804182
• UDI-Public: 07630030804182
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2018

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: 06/01/2022
• Device Catalogue Number: 01.18.142
• Device Lot Number: 170028
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/08/2018
• Supplement Date Received by Manufacturer: 05/08/2018
• Initial Report FDA Received Date: 06/07/2018
• Supplement Report FDA Received Date: 07/06/2018
• 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: 52 YR
• Patient Weight: 65