MAUDE Adverse Event Report: EXACTECH, INC. ALTEON; ALT HA S CLR STD SZ 7

Catalog Number 190-30-07

Device Problems Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924)

Event Date 05/01/2019

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Patient suffered a peri-prosthetic fracture during their original surgery.The fracture was cabled and the stem was placed.The ha collared stem ultimately subsided, requiring revision and placement of a monobloc stem.The explanted device will not be returning.

• Brand Name: ALTEON
• Type of Device: ALT HA S CLR STD SZ 7
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 8654664
• MDR Text Key: 146620513
• Report Number: 1038671-2019-00298
• Device Sequence Number: 1
• Product Code: MEH
• 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: 04/20/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 05/17/2022
• Device Catalogue Number: 190-30-07
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/01/2019
• Initial Date Manufacturer Received: 05/01/2019
• Initial Date FDA Received: 05/30/2019
• Supplement Dates Manufacturer Received: 03/27/2020
• Supplement Dates FDA Received: 04/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR