MAUDE Adverse Event Report: EXACTECH, INC. ALTEON; MONO REV STEM STD 20X195

Model Number	01-010-20-4195
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Failure of Implant (1924)
Date of Event	07/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant medical device: (cn: 170,36,03, sn:(b)(4)) biolox delta femoral.
Event or Problem Description
As reported, approximately 2 months postop the initial ltha, this (b)(6) y/o female patient, bmi 27.9, left hip was revised due to avascular necrosis left femoral head with collapse.The surgeon removed the exactech alteon monoblock stem and cemented a novation stem.The delta ceramic head was replaced with a new one.Patient was last known to be in stable condition following the event.Devices not returning due to hospital policy.
Additional Manufacturer Narrative
Section h10: (h3) the evaluation noted that the event was likely the result of either undersizing the femoral stem or insufficient bony support for the implant, which led to femoral stem subsidence.However, this cannot be confirmed because the component was not returned for evaluation.Concomitant device: (cn: 170,36,03, sn: (b)(6)) biolox delta femoral.Section h11: corrections made in the following section(s): (b3) event date corrected from (b)(6) 2020 to (b)(6) 2020.

• Brand Name: ALTEON
• Common Device Name: MONO REV STEM STD 20X195
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10561065
• Report Number: 1038671-2020-00544
• Device Sequence Number: 16849571
• Product Code: LZO
• UDI-Device Identifier: 10885862281913
• UDI-Public: 10885862281913
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K150066
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2020

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 Expiration Date: 08/10/2022
• Device Model Number: 01-010-20-4195
• Device Catalogue Number: 01-010-20-4195
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/28/2020
• Supplement Date Received by Manufacturer: 08/28/2020
• Initial Report FDA Received Date: 09/21/2020
• Supplement Report FDA Received Date: 11/05/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR