MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE GLENOSPHERE 38MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-06-38
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	09/30/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Concomitants: 320-38-00 145-deg pe 38mm hum liner +0 (b)(6).A10012 - gps implant kit v2 (b)(6).Exc-eqrv38-us - orthosensor 38mm usa (b)(6).300-30-10 - equinoxe preserve stem 10mm (b)(6).320-15-02 - rs glenoid plate sup (b)(6) deg (b)(6).531-20-00 - shldr gps rvrs drill kit (b)(6).531-78-20 - shouldr gps hex pins kit (b)(6).320-15-05 - eq rev locking screw (b)(6).320-10-00 - equinoxe reverse tray adapter plate tray +0 (b)(6).320-20-00 - eq reverse torque defining screw kit (b)(6).320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm (b)(6).320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm (b)(6).320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm (b)(6).320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm (b)(6).
Event or Problem Description
As reported, approximately 1 month post initial right total shoulder arthroplasty (tsa), the patient underwent revision of the prosthesis due to dislocation.The patient was wheelchair-bound and within the first couple weeks after implant, reached over a chair and dislocated the prosthesis.The surgeon proceeded to revise the patient to larger and constrained implants.The glenosphere, locking screw, and liner were swapped out.The event was not related to the breakage of a device.There was a surgical delay/prolongation of approximately 30-45 minutes in relation to the need for revision surgery due to the dislocation.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
The previous report was submitted in error.All relevant reporting for this event is captured under 1038671-2024-04563.As a result, this report may be disregarded.

• Brand Name: EQUINOXE GLENOSPHERE 38MM
• 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: geoff gannon ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 20822738
• Report Number: 1038671-2024-04565
• Device Sequence Number: 12716175
• Product Code: KWS
• UDI-Device Identifier: 10885862563699
• UDI-Public: 10885862563699
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K193098
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2025

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 Catalogue Number: 320-06-38
• 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: 11/13/2024
• Supplement Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 12/02/2024
• Supplement Report FDA Received Date: 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2020
• 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 H11
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 124 KG