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.

• 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
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct.; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523782617
• MDR Report Key: 11060999
• MDR Text Key: 224059061
• Report Number: 1038671-2020-00663
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162732
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer

Reporter Occupation

• 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

• Device Model Number: 190-30-08
• Device Catalogue Number: 190-30-08
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/22/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2016
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 12/22/2020 Patient Sequence Number: 1