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 Failure of Implant (1924)

Event Date 01/17/2023

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: concomitant products.Equinoxe reverse 38mm glenosphere (cat# 320-01-38 / serial# (b)(4).Equinoxe reverse 38mm humeral liner +0 (cat# 320-38-00 / serial# (b)(4).Additional information, including the product investigation, will be submitted within 30 days of receipt.

Event Description

As reported approximately one year post initial tsa, the female patient complained of pain.The doctor requested an mri and verified that the screw.Reverse glenosphere was broken.Verified by resonance that the prosthesis was correctly fixed.Explanted material will be sent for analysis.

Manufacturer Narrative

After further review of additional information received the following sections g3, g6, h2, h3 and h6 have been updated accordingly.(h3) the revision reported was likely the result of either off-axis seating of the glenosphere on the baseplate or incomplete seating of the glenosphere locking screw at the time of implantation.Incomplete seating of the screw may have been due to bone graft or allograft being retained on the screw-hole threads of the baseplate, the glenosphere locking screw being cross-threaded into the baseplate, or a combination of the two, which led to the inability to fully seat the glenosphere onto the baseplate.However, this cannot be confirmed as the devices were not returned for evaluation, and photographs of the explanted devices and immediate post-operative radiographs of the index surgery were not provided.The most probable root cause associated with the reported event of ¿screw breakage¿ is associated with a partial or full-thickness crack of a screw, either during implantation or sometime after.Furthermore, the most probable root cause associated with the event of ¿device dislodged or dislocated¿ is associated with the device not remaining in an expected location.Section d10: device available for evaluation.

• 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: 16541948
• MDR Text Key: 311289586
• Report Number: 1038671-2023-00435
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086495
• UDI-Public: 10885862086495
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K063569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2023
• 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: 08/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2021
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Female