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

Model Number 190-30-08

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Failure of Implant (1924)

Event Date 12/03/2020

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.Concomitant device: novation ehxl natural liner g3 36mm; (cn: 140-36-53, sn: (b)(4)).Alteon ha stem collared standard size 8 (cn: 190-30-08, sn: (b)(4)).Biolox delta femoral head 36mm od, +0mm (cn: 170-36-00, sn: (b)(4)).

Event Description

As reported, approximately 11 months postop the initial left tha.This (b)(6) y/o male with a history of osteoarthritis, was revised.The patient received a new xle 40mm lipped liner, a 19x245 monobloc and a 40mm +10 head.Devices not returning.The patient requested the implants.Patient was last known to be in stable condition following the event.

Manufacturer Narrative

Section h10: (h3) the evaluation of the of the revision reported was likely the result of an insufficient bond between the implant and the bone which led to aseptic loosening of the femoral stem.However, this cannot be confirmed because the component was not returned for evaluation.(d11) concomitant device: novation ehxl natural liner g3 36mm (cn: 140-36-53, sn: (b)(6).Alteon ha stem collared standard size 8 (cn: 190-30-08, sn: (b)(6).Biolox delta femoral head 36mm od, +0mm (cn: 170-36-00, sn: (b)(6).

• 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: 11060999
• MDR Text Key: 224059061
• Report Number: 1038671-2020-00663
• 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: 01/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 09/04/2023
• Device Model Number: 190-30-08
• Device Catalogue Number: 190-30-08
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/22/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR