MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE CAGE GLENOID M, POST AUG, RIGHT; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	314-13-33
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Osteolysis (2377); Implant Pain (4561); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.D10: 315-35-00 - glnd kwire.(b)(6).310-01-53 - equinoxe, humeral head short, 53mm (beta).(b)(6).300-30-06 - equinoxe preserve stem 6mm.(b)(6).300-20-02 - equinox square torque define screw drive kit.(b)(6).300-10-15 - equinoxe replicator plate 1.5mm o/s.(b)(6).
Event or Problem Description
As reported, approximately 5 years and 5 months post the initial right total shoulder replacement and right shoulder biceps tenodesis, the patient came in for an office visit and reported that they developed pain in the right shoulder about 2 years prior.X-ray of the right shoulder showed evidence of loosening of the glenoid component and osteolysis around the humeral component.The plan was for a ct scan of the right shoulder and aspiration of the joint to rule out infection.The patient's esr was elevated, but the crp, white count, aspiration, and cultures were all negative for infection.The surgeon explained to the patient that the test results are consistent with glenoid loosening with osteolysis in the glenoid.It was discussed that the plan moving forward would be a revision to a reverse shoulder replacement.However, in that there was a fair amount of bone loss in the glenoid, the patient would either require bulk allografting or a custom implant.5 years and 11 months post the initial total shoulder replacement the patient underwent right revision shoulder arthroplasty, conversion from anatomic to reverse shoulder arthroplasty, for right shoulder glenoid loosening.Intra-operatively it was noted that the polyethylene glenoid component was grossly loose and easily removed with a kocher.The glenoid component had become detached from the metallic cage.There was no peri-operative complications and the patient was discharged home the next day.At the post-operative visit the patient reported pain is well controlled on over-the-counter pain medications.The patient adhered to sling immobilization and regular home exercise protocol, denied interval trauma or injury since the time of surgery, and had no new complaints; denied numbness, tingling, or paresthesias in the operative extremity.Two radiographic views of the right shoulder demonstrated a custom reverse total shoulder arthroplasty prosthesis with no signs of mechanical failure.The glenosphere appeared to have increased inferior tilt.There was no evidence of loosening or fracture.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: g3/g4, h6.The following sections were corrected: h6.Mdr section codes updated/corrected: b, c, d, e, g.The reason for the revision reported cannot be confirmed from the information provided but may be the result of glenoid loosening, disassembly, and/or due to inclusion of the polyethylene in the packaging recall.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images, radiographs, and relevant clinical information were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: EQUINOXE CAGE GLENOID M, POST AUG, RIGHT
• 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: 20340894
• Report Number: 1038671-2024-03757
• Device Sequence Number: 20816009
• Product Code: KWS
• UDI-Device Identifier: 10885862201010
• UDI-Public: 10885862201010
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K113309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2025

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 Expiration Date: 07/25/2023
• Device Catalogue Number: 314-13-33
• 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: 09/17/2024
• Supplement Date Received by Manufacturer: 02/13/2025
• Initial Report FDA Received Date: 09/30/2024
• Supplement Report FDA Received Date: 02/14/2025
• Date Device Manufactured: 07/27/2018
• 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; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 89 KG
• Patient Race: White