MAUDE Adverse Event Report: EXACTECH, INC. ALTEON; ALT HA S CLR STD SZ 6

Model Number 190-30-06

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Date 11/27/2020

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

As reported, during the initial implantation of a tha, on this female patient after countersinking a size 6 broach in the patient's femoral canal the surgeon asked for a size 6 collared stem.While attempting to seat the implant to reproduce the position of the broach the patient's femur cracked.He then extracted the implant, applied cables to the femur and went through extensive broaching and re-broaching to get the implant to fit.This caused 30-45 mins delay in surgery.Patient was last known to be in stable condition following the event.Devices not returning, it is implanted into the patient.

Manufacturer Narrative

(h3) the evaluation of the of the reported event was, the surgical technique and patient conditions at the time of implantation of the total hip components.No information provided in the following section(s): a2, a4, a5, b6.The following section(s) have additional info: g4, g7, h1, h2, h3, and h7.

• Brand Name: ALTEON
• Type of Device: ALT HA S CLR STD SZ 6
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10972479
• MDR Text Key: 220632542
• Report Number: 1038671-2020-00644
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 10885862321084
• UDI-Public: 10885862321084
• Combination Product (y/n): N
• PMA/PMN Number: K162732
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 190-30-06
• Device Catalogue Number: 190-30-06
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK.
• Patient Outcome(s): Required Intervention