MAUDE Adverse Event Report: EXACTECH, INC. ALTEON; NECK PRESERVING STEM, STD OFFSET PLASMA SZ 4

Catalog Number 162-00-04

Device Problems Fracture (1260); Loose or Intermittent Connection (1371)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/25/2019

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.Concomitant medical products: biolox delta femoral head (cn: 170-36-93, sn: (b)(4)).Connexion gxl pe acetabular liner (cn: 130-36-53, sn: (b)(4)).

Event Description

This event report was received through clinical data collection activities.Revision due to periprosthetic fracture and loosening and subsidence of the femoral np implant.The case report form indicates this event was resolved with revision surgery on (b)(6) 2019.

Manufacturer Narrative

The engineering evaluation noted in the revision reported was likely the result of a fracture of the femur post-operatively, which led to loosening and subsidence of the femoral stem.However, the cause of the bone fracture could not be determined because no further information was provided.Concomitant devices: biolox delta femoral head (cn: 170-36-93, sn: (b)(4).Connexion gxl pe acetabular liner cn: 130-36-53, sn:(b)(4).

• Brand Name: ALTEON
• Type of Device: NECK PRESERVING STEM, STD OFFSET PLASMA SZ 4
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 8594956
• MDR Text Key: 144549509
• Report Number: 1038671-2019-00268
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: K121684
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/23/2021
• Device Catalogue Number: 162-00-04
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Weight: 95