MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE, HUMERAL HEAD SHORT, 44MM (ALPHA); PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	310-01-44
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Muscle/Tendon Damage (4532)
Date of Event	08/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.D10: 6819686 310-01-44 - equinoxe, humeral head short, 44mm (alpha), a970166 300-01-12 - equinoxe humeral stem primary press fit 12mm, a606789 300-10-45 - equinoxe replicator plate 4.5mm o/s, b013900 300-20-02 - equinox square torque define screw drive kit, a331826 314-23-03 - laser cage glenoid medium, alpha, a926906 321-52-09 - 3.2mm k-wire, trocar tip, b013655 321-52-10 - 3.2mm k-wire, thd, short 2 k-wires per pack.
Event or Problem Description
As reported, approximately 1 month and 22 days post the initial left tsa, the subscap repair failed and had to be fixed.The humeral head was removed in order to do so, then replaced.The patient was revised to exactech devices.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d1, d4, h4 g4, h6 mdr section codes updated/corrected: b, c, d, g.The reason for the shoulder revision reported is likely due to rotator cuff failure as reported.Contributions from patient-related issues, soft tissue tensioning, and/or component positioning or sizing issues to the reported event cannot be determined from the reported information.However, this cannot be confirmed because the evaluation of the returned device showed it was unremarkable for an explanted component.Relevant patient information, images, or radiographs were not provided either.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: EQUINOXE, HUMERAL HEAD SHORT, 44MM (ALPHA)
• 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: 20127676
• Report Number: 1038671-2024-03232
• Device Sequence Number: 14249937
• Product Code: KWS
• UDI-Device Identifier: 10885862083876
• UDI-Public: 10885862083876
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 09/11/2025

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: 310-01-44
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2024
• Supplement Date Received by Manufacturer: 09/10/2025
• Initial Report FDA Received Date: 09/03/2024
• Supplement Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2021
• 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 H11.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female