MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE GLENOID, CAGE PEGGED, BETA

Catalog Number 314-13-14

Device Problems Fracture (1260); Device Slipped (1584); Loosening of Implant Not Related to Bone-Ingrowth (4002)

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

Event Date 12/05/2017

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Index surgery: (b)(6) 2016.Revision due to loosening.

Manufacturer Narrative

The complaint products were not received for analysis.The reported malfunction of fractured prosthesis was not confirmed.The frequency of occurrence ranking scale is very low; therefore, this issue does not appear to be design-related.The company is not aware of receiving any complaint reports involving another part from these manufacturing lots of 50 (replicator plate), 50 (torque defining screw drive kit), 30 (cage glenoid) and 36 (humeral head) pieces that have been in the field since 2015.This does not appear to be manufacturing-related.User-related issues reported are that the original implanting surgeon had put the device in off axis and not to the proper depth.The prosthesis fracture of the caged glenoid reported was likely the result of the caged glenoid being implanted off of its axis and not to the proper depth, which allowed for the peripheral peg to partially break.However, this cannot be confirmed because the devices were not available for evaluation and adequate information was not provided.Operative technique guide review -for the cage glenoid and prior to insertion of the trial, use the provided depth gauge to ensure that the holes were prepared to the defined depth.If depth gauge is not fully seated, re-drill holes as needed.Ifu review -device specific risks include 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.Only qualified surgeons knowledgeable in anatomy, biomechanics, and reconstructive surgery should use these devices.The surgeon must be fully knowledgeable about: all aspects of surgical technique and use these implants in accordance with the respective indications and contraindications summarized in this document; about the compatibility of system components and use each device accordingly; and must be trained according to the proper use of the system instrumentation.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.

Event Description

It was reported that a patient experienced a total reverse shoulder revision due to loosening and prosthesis fracture."revision of a total to a reverse total shoulder from an alternate surgeon who incorrectly implanted a cage glenoid, causing loosening.According to the surgeon, the glenoid component had been clearly put in off axis and not to the proper depth, causing a peripheral peg to partially break.He was able to find the piece of the peripheral peg and removed it before converting the shoulder to a reverse, for fear of the subscap not healing properly on aging patient." there is no additional information provided on the patient or event.This is one of four products involved with the reported event and the associated manufacturer report numbers are 1038671-2017-00907, 1038671-2017-00908, 1038671-2017-00909.

• Brand Name: EQUINOXE GLENOID, CAGE PEGGED, BETA
• Type of Device: GLENOID
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• MDR Report Key: 7137916
• MDR Text Key: 95486650
• Report Number: 1038671-2017-00910
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: K113309
• 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: 04/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 05/05/2020
• Device Catalogue Number: 314-13-14
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention