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

Medical Device Problem Codes	Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	04/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 2 years post op initial left tsa, this 72 y/o male patient was revised.The patient originally had an exactech reverse shoulder implanted.At some point the glenosphere became disassociated from the baseplate.Another surgeon in (b)(6) il revised the shoulder implanting the above listed implants on (b)(6) 2021 at (b)(6)(captured in case: (b)(4).The baseplate and stem were not removed but screws were added and a new glenosphere and liner were implanted.After that case the glenoid baseplate became pulled out from the glenoid and was free floating in the shoulder based on xray.Surgeon scheduled a case to revise the shoulder to a hemi on (b)(6) 2023.During the case the surgeon exposed the humerus and removed both the liner and the +0 tray he then moved on to the glenoid where he was able to pull out the glenosphere including the baseplate and all screws.One screw had been broken off in the glenoid from a previous surgery or from when the glenoid component became loose.The broken screw was not retrieved and was left in the glenoid.Surgeon then implanted a 1.5 replicator plate (300-21-00 a197490) and 47 x 18 head (310-01-47 a373263).Surgeon did take 5 cultures to rule out infection, he closed and the checked stability and range of motion with both being good.Patient was last known to be in stable condition following the event.Product no being returned, reason: "patient requested explanted implants".
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation (d10) concomitant device(s): 4.5 x 30 screw, 320-20-30, s205705, 4.5 x 30 screw, 320-20-30, s205705, 4.5 x 30 screw, 320-20-30, s205723, 38 glenosphere, 320-06-38, 6917759, locking screw, 320-15-05, 6945519, torque screw, 320-20-00, 6943087, +0 adapter tray, 320-10-00, 6891833, 38 +2.5 liner, 320-38-03, s254497.
Event or Problem Description
As reported, approximately two years post op initial left tsa, this male patient was revised.The patient originally had an exactech reverse shoulder implanted.At some point the glenosphere became disassociated from the baseplate.Another surgeon in revised the shoulder implanting the the above listed implants.The baseplate and stem were not removed but screws were added and a new glenosphere and liner were implanted.After that case, the glenoid baseplate became pulled out from the glenoid and was free floating in the shoulder based on xray.Surgeon scheduled a revised the shoulder to a hemi.During the case, the surgeon exposed the humerus and removed both the liner and the +0 tray he then moved on to the glenoid where he was able to pull out the glenosphere including the baseplate and all screws.One screw had been broken off in the glenoid from a previous surgery or from when the glenoid component became loose.The broken screw was not retrieved and was left in the glenoid.Surgeon then implanted a 1.5 replicator plate and 47 x 18 head.Surgeon did take five cultures to rule out infection.He closed the sight and checked stability and range of motion with both being good.Patient was last known to be in stable condition following the event.Product not being returned.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected/additional information.The following sections were corrected/added: b1, b2, b5, d1, d4 (remove all data from initial report - catalog number unknown), d6a (remove date-unknown), d8, g1, g4, h4 (remove date) h6: clinical code, medical device problem code, type of investigation, investigation findings and investigation conclusions.The revision reported was likely the result of loosening of the glenoid baseplate, and eventual migration of the construct from the glenoid bone.The contribution of the broken compression screw to the loosening cannot be determined because it is unclear when the fracture occurred.Potential contributions of user or patient-related considerations to the event could not be assessed, and the sequence of events cannot be determined because the revised components were not returned for evaluation and no images or serial radiographs were provided.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: EQUINOXE REVERSE GLENOID BASEPLATE
• 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: geoff gannon ; 2320 nw 66th ct; gainesville 32653 ; 3523771140
• MDR Report Key: 17037723
• Report Number: 1038671-2023-01193
• Device Sequence Number: 12376951
• Product Code: KWT
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2026

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 Expiration Date: 03/04/2026
• 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: 04/27/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/01/2023
• Supplement Report FDA Received Date: 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/11/2021
• 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: Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male