MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; RS EXPANDED GLENOSPHERE 42MM, +4MM OFFSET

Catalog Number	320-02-42
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	11/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluated by manufacturer? pending evaluation.Concomitant medical device(s): 2.5+ cnstr lnr (cat# 320-42-13 / sn# (b)(4)); rev torque screw (cat# 320-20-00 / sn# (b)(4)); +10 hum tray (cat# 320-10-10 /sn# (b)(4)); 13mm hum stem (cat# 300-11-13 / sn# (b)(4)); glen locking screw (cat# 320-15-05 / sn# (b)(4)).
Event or Problem Description
This patient had his primary surgery in of (b)(6) 2019, then he was dislocating so the doctor revised him.He pulled out the stem, tray, and liner.He also replaced the glenosphere.The +10 tray disassociated from the stem.The screw on the disassociated tray was not broken or stripped.
Additional Manufacturer Narrative
Section h10: (h3) the revision reported was likely the result of incomplete seating of the torque defining screw during the index surgery, allowing for the humeral tray to disassociate from the humeral stem.The disassociation of the torque defining screw likely contributed to the reported dislocations.Section h11: the following sections have corrected information: (b5) describe event or problem: as reported, this patient was dislocating and was revised.The surgeon replaced the stem, tray, liner, and glenosphere.The +10 tray was disassociated from the stem.Dr.Wright tightened the screw himself when the shoulder was put in, so he is confident the torque kit was tight.The screw on the disassociated tray was not broken or stripped.He would really like to know the results of any investigation into this experience report.The initial date of surgery was (b)(6) 2019.
Event or Problem Description
As reported, this patient was dislocating and was revised.The surgeon replaced the stem, tray, liner, and glenosphere.The +10 tray was disassociated from the stem.Dr.Wright tightened the screw himself when the shoulder was put in, so he is confident the torque kit was tight.The screw on the disassociated tray was not broken or stripped.The initial date of surgery was (b)(6) 2019.

• Brand Name: EQUINOXE
• Common Device Name: RS EXPANDED GLENOSPHERE 42MM, +4MM OFFSET
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9328136
• Report Number: 1038671-2019-00568
• Device Sequence Number: 2498235
• Product Code: KWT
• UDI-Device Identifier: 10885862186768
• UDI-Public: 10885862186768
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K110708
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2020

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
• Operator of Device: Health Professional
• Device Catalogue Number: 320-02-42
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/06/2019
• Supplement Date Received by Manufacturer: 04/01/2020
• Initial Report FDA Received Date: 11/15/2019
• Supplement Report FDA Received Date: 04/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Weight: 57