MAUDE Adverse Event Report: EXACTECH, INC. TIBIAL INSERT FB SIZE 1 8MM

Catalog Number 350-21-22

Device Problems Device Dislodged or Dislocated (2923); Migration (4003)

Patient Problems Joint Disorder (2373); No Code Available (3191)

Event Date 04/13/2018

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Index surgery: (b)(6) 2018.Pending revision of a tibial insert and locking clip due to the locking disengaging.

Event Description

It was reported that a patient had a revision surgery due to the tibial insert and the ankle locking clip disengaged.No additional information was provided.This is one of two products involved with the reported event and the associated manufacturer report numbers are 1038671-2018-00277 and 1038671-2018-00278.

Manufacturer Narrative

Section h3: the complaint product was not returned for analysis.The complaint condition was not confirmed.The frequency of occurrence ranking scale is very low; therefore, this does not appear to be design-related.The company is not aware of receiving any other complaint reports involving another part from these manufacturing lots of 30 (tibial insert) and 30 (locking clip) pieces that have been in the field since 2016 and 2017, respectively.Therefore, this does not appear to be manufacturing-related.The disassembled ankle locking clip reported was likely the result of the locking clip not being fully engaged at the time of initial surgery.This allowed the clip to disengage over time.However, this cannot be confirmed because the devices were not available for evaluation and adequate information was not provided.There is no patient information provided; therefore, it is not possible to assess the patient risk/clinical factors.Section h6: in a review of labeling - utilization and implantation component selection depends upon the judgment of the surgeon with relationship to the requirements of the patient.The surgeon shall become thoroughly familiar with the surgical technique of these prostheses by: appropriate reading of the literature, specific training in the operative skills and techniques required for the implant system, and reviewing any other relevant information regarding the use of instrumentation designed for device implantation.As part of the pre-operative 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, tilt, or migrate on the talus or distal tibia; fracture of host bone should also be considered.Such events could result in adverse outcome.The size of the talar component must be the same as the size of the liner component.All sizes of the liner component are compatible with all sizes of the tibial component.The size of the tibial component must be the same as the size of the locking piece.Device specific risks are: 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; and disassociation of modular components.As post-operative precautions- all patients should be instructed on the limitations of the prosthesis and the possibility of subsequent surgery.The patient should be cautioned to monitor activities and protect the replaced joint from unreasonable stresses and follow the written instructions of the physician with respect to follow-up care and treatment.Patients should be warned to protect the joint replacement from unreasonable stresses and to follow the treating physician's instructions, until anterior wound healing is complete.Patients must be informed that their weight and activity level may affect the longevity of the implant.Patients must be warned to avoid high impact activities such as running and jumping.This device is used for treatment not diagnosis.In the investigation of this event additional information was requested about the patient, devices, and event; no additional information was provided.

• Brand Name: TIBIAL INSERT FB SIZE 1 8MM
• Type of Device: TIBIAL INSERT FB
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• MDR Report Key: 7391923
• MDR Text Key: 104163073
• Report Number: 1038671-2018-00278
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• PMA/PMN Number: K152217
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/23/2019

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
• Device Operator: Physician
• Device Catalogue Number: 350-21-22
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/22/2018
• Initial Date FDA Received: 04/03/2018
• Supplement Dates Manufacturer Received: 06/18/2019
• Supplement Dates FDA Received: 06/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention