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

Model Number	320-01-38
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	01/12/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.D10: humeral stem or stemless 300-01-11; reverse humeral liner 320-38-00; reverse humeral tray 320-10-00; reverse glenosphere baseplate 320-15-01.
Event or Problem Description
As reported via clinical study, the patient had an initial left tsa on (b)(6) 2019.The patient presented to the surgeon on (b)(6) 2021 with disassociation of the glenosphere and reported pain and functional impotence.The patient was revised on (b)(6) 2022 and the glenosphere removed.Outcome: resolved.The case report form indicates this event is definitely not related to the devices or procedure.
Additional Manufacturer Narrative
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 images and radiographs were unable to be obtained.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.Results 2 of 2: the revision reported may have been due to 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 images and radiographs were unable to be obtained.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d1, d4.The revision reported may have been due to 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 images and radiographs were unable to be obtained.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 17001286
• Report Number: 1038671-2023-01137
• Device Sequence Number: 20625199
• Product Code: KWT
• UDI-Device Identifier: 10885862086495
• UDI-Public: 10885862086495
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/19/2025

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: 320-01-38
• Device Catalogue Number: 320-15-05
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/04/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2023
• Supplement Date Received by Manufacturer: 08/09/2023; 05/23/2025; 11/19/2025
• Initial Report FDA Received Date: 05/25/2023
• Supplement Report FDA Received Date: 08/23/2023; 05/29/2025; 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 81 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White