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

Model Number	01-010-24-4245
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	02/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem 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.
Additional 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
• Common Device Name: MONO REV STEM STD 24X245
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9947879
• Report Number: 1038671-2020-00268
• Device Sequence Number: 2815296
• Product Code: LZO
• UDI-Device Identifier: 10885862282187
• UDI-Public: 10885862282187
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K150066
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,s
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 01-010-24-4245
• Device Catalogue Number: 01-010-24-4245
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/24/2020
• Supplement Date Received by Manufacturer: 09/17/2020
• Initial Report FDA Received Date: 04/10/2020
• Supplement Report FDA Received Date: 10/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Weight: 70