MAUDE Adverse Event Report: EXACTECH, INC. ALTEON; MONO REV STEM STD 24X245

Model Number 01-010-24-4245

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Date 02/10/2020

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

As reported, this (b)(6) y/o female weight (b)(6) lbs and a history of hypertension was initially implanted with a tha.The patient presented with a periprosthetic femoral fracture approximately 4 days postop that was described as a conflict between femoral stem and femoral diaphysis is identified with lineal fracture from tip of stem.The revision procedure was an augmentation of femur diaphysis with plate resolution.The patient was discharged with a walker to a relative¿s home on 1 day postop.Devices will not be returned as this is a clinical study patient.No other information is available at this time.Note the patient entered the study on (b)(6) 2020 with a revision of exactech devices due to aseptic loosening.Case (b)(4) has been opened to captured this revision.

Manufacturer Narrative

Section h10: (h3) the evaluation noted that based upon on review of the available information, there is no evidence that this is a device related problem and there is no allegation against the device.The most likely cause of the reported event was a fracture which was likely caused by the femoral canal not being broached deep enough or perhaps there was something unique/unexpected with the patient¿s femoral anatomy/bone quality.

• Brand Name: ALTEON
• Type of Device: MONO REV STEM STD 24X245
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9947879
• MDR Text Key: 189068112
• Report Number: 1038671-2020-00268
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10885862282187
• UDI-Public: 10885862282187
• Combination Product (y/n): N
• PMA/PMN Number: K150066
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Type of Report: Initial,Followup
• Report Date: 10/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 01-010-24-4245
• Device Catalogue Number: 01-010-24-4245
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 70