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 Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Arthralgia (2355); Osteolysis (2377); Joint Laxity (4526); Joint effusion (4849)
Date of Event	10/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this patient underwent right total shoulder replacement and right shoulder biceps tenodesis for osteoarthritis and biceps tendinitis of the right shoulder.The patient was discharged home.The patient did well postoperatively for 4+ years.He presented for an office visit at which time he reported he developed pain about a year ago.Xr of the right shoulder showed some superior migration of the humeral head.Disruption of the titanium pegs on the back of the glenoid component was questioned.Ct scan done, surgeon discussed with the patient on that the ct showed loosening of the glenoid component, and discussed revision to reverse should replacement, which the patient was going to think about.At office visit, on right shoulder x-ray showed "anatomic shoulder replacement in alignment.There is some superior migration of the humeral head.There is some disruption of the titanium pegs on the back of the glenoid component." the patient underwent right shoulder revision - reverse shoulder placement and right arthrotomy shoulder biceps tenodesis for loosening of the glenoid associated with pain.Intraoperatively there were no gross signs for infection.Humeral component was solidly fixed.The glenoid was grossly loose.It was removed.Patient tolerated surgery well without complications.Post-operative x-ray impression was "right reverse shoulder arthroplasty without evidence of complication." discharge summary notes, "orthopedically uneventful hospital course.Patient was given 24 hours of routine perioperative iv antibiotics.Patient tolerated physical therapy and achieved all necessary goals for discharge." the patient was discharged home.
Additional Manufacturer Narrative
(h3) pending evaluation (d10) concomitant device(s): stem hum shrt equinoxe preserve 7mm - exactech plate replicator 4.5 mm offset- exactech cmnt bone smpx p radopq fd sterile - stryker screw kit equinoxe torque sq - exactech head humeral 50mm shldr equinoxe short exactech reporting site gnv.
Additional Manufacturer Narrative
The reported glenoid loosening may be secondary to superior migration of the humeral head resulting from the reported rotator cuff deficiency.However, the sequence of events cannot be confirmed, and the failure and potential contributions from manufacturing, patient, or user-related issues to the event cannot be confirmed as the devices were not returned for evaluation and no images or radiographs were provided.B3: corrected h6: corrected health effect and investigation clinical codes.

• 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; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 20724241
• Report Number: 1038671-2024-04425
• Device Sequence Number: 6583591
• 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: 2019
• Device Explanted Year: 2024
• 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): 05/08/2025

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 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: 10/30/2024
• Supplement Date Received by Manufacturer: 05/08/2025
• Initial Report FDA Received Date: 11/19/2024
• Supplement Report FDA Received Date: 05/08/2025
• Date Device Manufactured: 10/20/2020
• 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 Sex: Male
• Patient Weight: 83 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White