MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE TORQUE DEFINING SCREW SQUARE DRIVE KIT; TORQUE DEFINING SCREW KIT

Catalog Number 300-20-02

Device Problems Material Erosion (1214); Naturally Worn (2988)

Patient Problems Joint Disorder (2373); No Information (3190)

Event Date 02/05/2018

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Index surgery: (b)(6) 2012.Revision of shoulder components due to wear.

Event Description

It was reported that a patient experienced a revision surgery of right shoulder components due to wear.The humeral head and replicator plate were removed with standard instruments.The glenoid component had worked itself loose and was easily removed with its cement mantle attached.The reverse was then completed after labs came back clear.The reverse shoulder technique was completed without incident.The glenoid required significant bone grafting.No additional information has been provided about the event or the patient.This is one of five products involved with the reported event and the associated manufacturer report numbers are 1038671-2018-00228, 1038671-2018-00230, 1038671-2018-00231 and 1038671-2018-00232.

Manufacturer Narrative

Section h3: the complaint products were not returned for analysis.The device condition of wear was not confirmed.The frequency of occurrence ranking is very low; therefore, this does not appear to be a design issue.The company is not aware of receiving any other complaint reports involving another part from this manufacturing lot of 50 (replicator plate), 49 (torque screw square drive kit), 32 (humeral stem), 34 (glenoid) and 50 (humeral head) pieces that have been in the field since 2012, 2012, 2012, 2010 and 2012, respectively.Therefore, this issue does not appear to be manufacturing related.Aseptic glenoid loosening and prosthesis wear as a long-term complication is predictable in active patients.The prosthesis wear reported was likely the result of being implanted for 6 years and experiencing loads consistent with patient body weight during normal activities.However, this cannot be confirmed because the devices were not available for evaluation and adequate information was not provided.Section h6: in a review of the labeling, it is known that device specific risks consist of: fracture, migration, loosening, subluxation, or dislocation of the prothesis or any of its components, any of which may require a second surgical intervention or revision.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.Revisions or surgical interventions are a known complication found in joint replacements.It is known to be contraindicated in the following situations: patients whose weight, age, or activity level might cause extreme loads and early failure of the system.There is no patient information provided; therefore, it is not possible to assess the patient risk/clinical factors.This device is used for treatment not diagnosis.In the investigation of this event, additional information has been requested.No new information has been provided.Section(s): no information a2, a4-6.

• Brand Name: EQUINOXE TORQUE DEFINING SCREW SQUARE DRIVE KIT
• Type of Device: TORQUE DEFINING SCREW KIT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• MDR Report Key: 7340885
• MDR Text Key: 102453707
• Report Number: 1038671-2018-00229
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• PMA/PMN Number: K042021
• 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: 05/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 05/06/2017
• Device Catalogue Number: 300-20-02
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention