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

Model Number	320-15-05
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/13/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluated by mfr: pending evaluation.Concomitant device(s): 320-31-36, 7129906 - glenosphere, 36mm, 320-35-01, 7180131 - small glenoid plate, 320-20-00, 7165747 - eq reverse torque defining screw kit.
Event or Problem Description
As reported, approximately 3 months postop the initial fracture rsa, the female patient had complained of pain, the surgeon found by x-ray that the screw had backed out from the appropriate position.As a result, the surgeon decided to perform revision surgery.The liner, glenosphere and locking screw only were replaced.The glenoid plate was not replaced due to the assembly condition between glenoid base plate and locking screw that used at primary surgery was confirmed and it was noted that the locking screw could not insert into the hole of the glenoid base plate correctly.Based on the this, a new locking screw was tried and could be inserted into the hole of glenoid base plate that was used by primary surgery correctly.The surgeon did note that during the primary rsa, when he placed the glenosphere, he found an osteophyte above the glenoid, and removed it.He noted this step may have affected the placement/seating of the glenosphere fully.The locking screw was noted to have fully come off, so the removal procedure of implants was easy.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
Section h10: (d4) serial number: (b)(6), expiration date: 09-nov-2026.(h3) the revision reported was likely the result of not fully seating the glenosphere on the baseplate, possibly due to incomplete removal of an osteophyte above the glenoid, which led to incomplete seating/cross-threading of the glenosphere locking screw at the time of implantation.Incomplete seating of the screw likely allowed the screw to back out overtime and caused the glenosphere to become loose on the baseplate.(h4) device manufacture date: 11-nov-2021.

• Brand Name: EQ REV LOCKING SCREW
• Common Device Name: 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 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 14843136
• Report Number: 1038671-2022-00742
• Device Sequence Number: 14048937
• Product Code: KWT
• UDI-Device Identifier: 10885862086495
• UDI-Public: 10885862086495
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2023

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 Model Number: 320-15-05
• Device Catalogue Number: 320-15-05
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2022
• Supplement Date Received by Manufacturer: 03/31/2023
• Initial Report FDA Received Date: 06/28/2022
• Supplement Report FDA Received Date: 04/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female