MAUDE Adverse Event Report: EXACTECH, INC. EQ REV LOCKING SCREW; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number EQ REV LOCKING SCREW

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/07/2022

Event Type  Injury  

Event Description

As reported, approximately two years post initial left tsa, the 78 y/o patient had an original left reverse total shoulder arthroplasty surgery on (b)(6) 2021.The patient presented to surgeon's office with pain and poor motion in the left reverse tsa.An examination was performed and imaging was obtained including x-rays and ct imaging of the left shoulder.The surgeon determined that the glenoid implant was not in the correct position for this patient's anatomy.The imaging showed and confirmed a broken glenoid compression screw.The patient was scheduled for a revision reverse tsa, removal, and revision of the baseplate/glenosphere, replacement.The revision surgery was performed on (b)(6) 2022.The surgeon opened the shoulder and exposed the shoulder joint implants.The reverse liner was removed used a curved osteotome, and the reverse tray and torque screw securing it was removed from the stem.The stem implant (equinoxe humeral stem primary press fit 12mm 300-01-12 , (b)(4)) was checked using the stem inserter handle for the correct version, and the stem is secure/well fixed.The version was confirmed acceptable and in the correct position and the stem was secure or well-fixed.The surgeon then exposed and addressed the glenoid.The surgeon obtained cultures of the shoulder joint fluid to be sent for examination and rule out of any infection presence.The glenosphere screw was removed using the 3.5 hex driver.The glenosphere was removed using a curved osteotome and kocher.There was unfavorable tissue/fluid behind the glenosphere implant.The locking caps were removed from all 6 holes of the glenoid baseplate.There was 4 total screws that were implanted into he baseplate, but all 6 holes were capped with caps even though some holes did not contain a compression screw.The compression screws within the baseplate were then removed using the screwdriver, the surgeon noted that the compression screws were loose.He did not feel that they had good or tight fixation.He removed the head of the broken screw that was in the inferior posterior hole.The remaining broken threaded part of the screw was left in the glenoid bone.The surgeon noted that the trajectory of the broken screw was incorrect and would not affect his putting in the revision implant.He felt it could cause more bone loss or issues to try to explant the broken screw than to leave it within the bone and patient.The patient was revised to an exactech +5 humeral tray and +2.5, 40mm humeral liner.The patient was revised to a competitor's central screw in baseplate, glenoid screws, and size 40 glenosphere.As of note: "there was one glenoid screw that broke within the glenoid bone from the original surgery.It is unclear which screw exactly from the initial surgery is the one that broke.The surgeon was able to remove the compression head of the screw but the remaining portion of the broken screw (the threaded portion) was left within the patient and within the glenoid bone.The surgeon commented that the screw was pointing in the incorrect trajectory for fixation and placement.The surgeon did not feel the broken screw was in the way of being able to implant new screws in the correct trajectory and could potentially create more damage or bone loss by explanting it.There was a 30-45 minute surgical delay.No adverse events as a result".

Manufacturer Narrative

Additional information, including the product investigation, will be submitted within 30 days of receipt.

Manufacturer Narrative

Section h10: (h3) the revision reported was likely the result of improper positioning of a compression screw resulting in compression screw loosening, compression screw breakage, and glenoid baseplate loosening.The extent and root cause of the compression screw breakage and glenoid baseplate loosening cannot be determined as the devices were not returned for evaluation, and pre-revision radiographs were not provided.One image of the explanted devices was provided, but a visual examination of the devices could not be conducted using this image.

• Brand Name: EQ REV LOCKING SCREW
• Type of Device: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16109389
• MDR Text Key: 306779620
• Report Number: 1038671-2023-00022
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086495
• UDI-Public: 10885862086495
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EQ REV LOCKING SCREW
• Device Catalogue Number: 320-15-05
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: EQ REV LOCKING SCREW; EQ REVERSE TORQUE DEFINING SCREW KI; EQUINOXE HUMERAL STEM PRIMARY PRESS FIT 12MM; EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0; GLENOSPHERE 38MM; RS GLENOID PLATE SUP AUG, 10 DEG
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female