MAUDE Adverse Event Report: EXACTECH, INC. EXACTECH; SPECIFIC DEVICE NOT REPORTED

Catalog Number 9999

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Insufficient Information (4580)

Event Date 01/01/2020

Event Type  malfunction  

Event Description

It was reported from the us that information was received from a clinician meeting of alteon users.The following information is all that was reported.Slight subsidence observed in 1 month follow-up visit.Multiple email requests were sent to the contacts for additional information.No additional information was provided by the contacts related to this event.

Manufacturer Narrative

As a result of an fda inspection conducted in jan 2020, exactech, fei (b)(4), has committed to remediating 3 years of complaints (2017-2020).This mdr is being submitted as part of that remediation.Device(s) not available for evaluation.Eng eval completed by nf on (b)(6) 2020.Design-related issues: exactech is aware of 19 complaint reports due to femoral stem subsidence (7 revised, 12 non-revised) since 2008.Of the 19 complaints, 2 complaint involved alteon ha femoral stems.Mfg-related issues: manufacturing data could not be reviewed because the serial/lot information was not provided.Corrective actions are not required because migration of the prosthesis is listed in the product labeling (ifu 700-096-018 rev u), the occurrence rate is ¿very low¿, and the risk is captured in the rmr.The femoral stem subsidence reported may have been the result of either under sizing the femoral stem compared to the patient¿s anatomy or insufficient bony support for the implant.However, this cannot be confirmed as the patient had not been revised at the time of this investigation; therefore, the device was not available for evaluation.It is noted in ifu 700-096-018 that only qualified surgeons are to use these products: who are fully knowledgeable about all aspects of the surgical technique and use of these implants, have full knowledge about the system compatibility¿s, and must be fully trained to properly use the system and instrumentation.Also, as part of the preoperative assessment, the surgeon must ensure that no biological, biomechanical, or other factors exist that might adversely affect the surgery and/or postoperative period.Bone quality must be considered to ensure that the prostheses does not subside or migrate within the femoral canal or acetabulum; fracture of host bone should also be considered.Device specific risks - fracture, migration, loosening, subluxation, or dislocation of the prosthesis or any of its components, any of which may require a second surgical intervention or revision.This device is used for treatment not diagnosis.Based on review of all available information, there is no evidence to reasonably suggest the reported event is related to any manufacturing issues or design issues.The patient has device subsidence without reported revision.Device specific risks included the following: fracture, migration, loosening, subluxation, or dislocation of the prosthesis or any of its components, any of which may require a second surgical intervention or revision.An investigation was conducted; the femoral stem subsidence reported may have been the result of either under sizing the femoral stem compared to the patient¿s anatomy or insufficient bony support for the implant.However, this cannot be confirmed as the patient had not been revised at the time of this investigation; therefore, the device was not available for evaluation.

• Brand Name: EXACTECH
• Type of Device: SPECIFIC DEVICE NOT REPORTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; lph; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct.; gainesville FL 32563
• Manufacturer Contact: kate jacobson
• MDR Report Key: 14149946
• MDR Text Key: 290068240
• Report Number: 1038671-2022-00431
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141797
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/13/2020
• Initial Date Manufacturer Received: 02/13/2020
• Initial Date FDA Received: 04/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other