MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE SHOULDER COMPONENTS; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	GLENOSPHERE 42MM
Medical Device Problem Codes	Unstable (1667); Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Dislocation (2374); Joint Laxity (4526)
Date of Event	08/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, this patient had an initial right tsa on (b)(6) 2022.The patient was revised on (b)(6) 2022 due to instability.The patient was last known to be in stable condition following the event.The device is not returning as it is against hospital policy.
Additional Manufacturer Narrative
Pending investigation.Concomitant medical products: 10099121311, a10012 - gps implant kit v2; 7216388, 300-30-07 - equinoxe preserve stem 7mm; 7219124, 531-55-88 - ergo gps 3.2mm drill kit sterile; a006145, 531-78-20 - shouldr gps hex pins kit; a026732, 320-15-05 - eq rev locking screw; a044129, 320-10-00 - equinoxe reverse tray adapter plate tray +0; a047191, 320-15-01 - eq rev glenoid plate; a051891, 320-20-00 - eq reverse torque defining screw kit; s277124, 320-20-42 - eq rev compress screw lck cap kit, 4.5 x 42mm; s336665, 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm; s339164, 320-42-00 - equinoxe reverse 42mm humeral liner +0; s369617, 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm.
Additional Manufacturer Narrative
H3: based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of surgical revision for instability cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, b5, d1, d4 (remove all from initial report-suspect product unknown), h4 (remove erroneously entered date from initial report, h6: clinical codes, medical device problem codes, component code, type of investigation, investigation findings, investigation conclusion.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of surgical revision for instability/dislocation cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Event or Problem Description
It was reported a patient underwent a right reverse shoulder arthroplasty.Subsequently, the patient " became unstable".As a result, one (1) month later, the patient underwent a revision for instability and dislocation.The patient was last known to be in stable condition following the event.No further patient impact was reported.No additional information is available.

• Brand Name: EQUINOXE REVERSE SHOULDER COMPONENTS
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-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: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15390547
• Report Number: 1038671-2022-01068
• Device Sequence Number: 5707675
• Product Code: KWS
• UDI-Device Identifier: 10885862563712
• UDI-Public: 10885862563712
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/08/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: GLENOSPHERE 42MM
• Device Catalogue Number: 320-06-42
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2022
• Supplement Date Received by Manufacturer: 09/26/2022; 10/08/2025
• Initial Report FDA Received Date: 09/09/2022
• Supplement Report FDA Received Date: 10/13/2022; 10/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2021
• 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: Hospitalization; Required Intervention
• Patient Age: 82 YR
• Patient Sex: Male