MAUDE Adverse Event Report: EXACTECH, INC. ALTEON; ALT HA S CLR STD SZ 8

Model Number 190-30-08

Device Problem Migration (4003)

Patient Problem Failure of Implant (1924)

Event Date 09/02/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant device: (cn: 170-36-93, sn: (b)(4)) 36 -3.5 biolox head.

Event Description

As reported, approximately 1 year postop the initial tha, this (b)(6) male, patient was revised.The stem subsided laterally and became loose within patient, causing pain and discomfort.The alteon ha stem that was loose and taken out was a 36mm -3.5 offset biolox head.The surgeon put in a monobloc stem and new 36mm +0 offset biolox head.The zb g7 cup and liner was left in the hip.The surgeon used a combination of exactech/zb on initial surgery date.Patient was last known to be in stable condition following the event.Devices will not return as hospital disposed of them.

Manufacturer Narrative

(h3) the evaluation of the reported revision was likely the result of was likely the result of either under sizing the femoral stem for the patient¿s anatomy/femoral bone or insufficient bony support for the implant.However, this cannot be confirmed as the devices were not returned for evaluation.Concomitant device: (cn: 170-36-93, sn: (b)(6) 36 -3.5 biolox head.

• Brand Name: ALTEON
• Type of Device: ALT HA S CLR STD SZ 8
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10564160
• MDR Text Key: 208152956
• Report Number: 1038671-2020-00552
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 10885862321107
• UDI-Public: 10885862321107
• Combination Product (y/n): N
• PMA/PMN Number: K162732
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 10/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 06/03/2024
• Device Model Number: 190-30-08
• Device Catalogue Number: 190-30-08
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/04/2020
• Initial Date FDA Received: 09/21/2020
• Supplement Dates Manufacturer Received: 09/25/2020
• Supplement Dates FDA Received: 10/20/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention