MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE CAGE GLENOID S, POST AUG, LEFT; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	314-13-22
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	03/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the patient had an initial left tsa on (b)(6) 2019.The patient was revised on (b)(6) 2023.It appears as though the glenoid failed.It looks like the poly sheared off at the center peg junction.The patient was converted to a reverse shoulder.There was no reported breakage of device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.No other patient information/medical history reported.
Additional Manufacturer Narrative
Pending investigation.D10: 5753922 300-30-08 - equinoxe preserve stem 8mm; 5975579 300-51-15 - 1.5 short fa rep plt kit; 5995798 310-01-44 - equinoxe, humeral head short, 44mm (alpha); 5941178 314-13-22 - equinoxe cage glenoid s, post aug, left; 4869279 315-35-00 - glnd kwire; 6032249 531-78-20 - shoulder gps hex pins kit.
Additional Manufacturer Narrative
H3: the revision reported may have been the result of the center cage/center polyethylene peg detaching from the polyethylene body possibly as a result of off-axis drilling, incomplete seating of the cage glenoid during implantation, patient-related conditions, or any combination of these possibilities.However, this cannot be confirmed as the devices were not returned for evaluation, and immediate post-operative radiographs of the index surgery and pre-revision radiographs were unable to be obtained.

• Brand Name: EQUINOXE CAGE GLENOID S, POST AUG, LEFT
• 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: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16766277
• Report Number: 1038671-2023-00743
• Device Sequence Number: 15165975
• Product Code: KWT
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K113309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/03/2026

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: 03/27/2024
• Device Model Number: 314-13-22
• Device Catalogue Number: 314-13-22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2023
• Supplement Date Received by Manufacturer: 08/28/2023; 05/12/2026; 06/03/2026
• Initial Report FDA Received Date: 04/18/2023
• Supplement Report FDA Received Date: 09/11/2023; 05/29/2026; 06/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2019
• 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 Age: 73 YR
• Patient Sex: Female