MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE HUMERAL STEM PRIMARY PRESS FIT 17MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	300-01-17
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3: date of event unknown.D6b: explanted date unknown.D10: 314-02-34 - uhmwpe post aug glenoid large, right: (b)(6), 310-01-53 - equi, humeral head short, 53mm (beta): (b)(6), 300-10-45 - equi replicator plate 4.5mm o/s: (b)(6), 300-20-02 - equi square torque define screw drive kit: (b)(6).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.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported that the patient underwent an initial total shoulder replacement on the right side.Subsequently, the patient underwent a revision procedure.It was reported that the glenoid was completely eroded and came out in fragments.All pieces of the implant that remained were removed and the area was thoroughly debrided.The surgeon had considered keeping the stem, but upon inspection it was loose and came out with minimal effort.The patient was revised to a competitor's devices.The patient was last known to be in stable condition following the event.Images and x-rays were provided.No devices were not returned for evaluation.No other information is available.

• Brand Name: EQUINOXE HUMERAL STEM PRIMARY PRESS FIT 17MM
• 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 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 22898986
• Report Number: 1038671-2025-02842
• Device Sequence Number: 12974790
• Product Code: KWS
• UDI-Device Identifier: 10885862079343
• UDI-Public: 10885862079343
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K061454
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/26/2025

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: 04/19/2023
• Device Catalogue Number: 300-01-17
• 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: 08/21/2025
• Initial Report FDA Received Date: 08/26/2025
• Date Device Manufactured: 04/29/2013
• 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: Hospitalization; Required Intervention
• Patient Sex: Male