MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Catalog Number	300-01-11
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	07/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(d10) concomitant device(s): 310-01-44: equinoxe, humeral head short, 44mm (alpha) 300-10-15: equinoxe replicator plate 1.5mm o/s 314-13-03: equinoxe cage glenoid medium, alpha.
Event or Problem Description
As reported by the equinoxe shoulder study, during a left revision tsa, the patient experienced an intra-operative humeral fracture.It was additional reported that per email received "you are absolutely right the humeral stem was removed during the first revision in summer of 2019.The patient remained without any implant in the shoulder while the bone healed.The reverse pte was reimplemented in late fall of 2019" the patient underwent a revision procedure, and the event is now considered resolved.The clinical report indicates that the event is definitely not related to the device(s) and possibly related to the procedure.This event report was received through clinical data collection activities and no device return is anticipated.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: h6, h11.The reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.Operative notes and/or medical records were not provided for review of usage/ technique.A review of complaint history determined that no further action is required as no trends were identified.A review of manufacturing data was unable to be performed as the lot information of the product involved in the event was not available.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: h6, h11.The following sections were corrected: b2, b3, d6b, h6.The reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.Operative notes and/or medical records were not provided for review of usage/ technique.A review of complaint history determined that no further action is required as no trends were identified.A definitive root cause was unable to be determined; however, may have resulted from an intra-operative bone fracture.The cause of the bone fracture cannot be conclusively determined but may be related to a patient condition and/or surgical techniques.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
(d10): 310-01-44: equinoxe, humeral head short, 44mm (alpha).300-10-15: equinoxe replicator plate 1.5mm o/s.314-13-03: equinoxe cage glenoid medium, alpha this follow-up report is being submitted to relay corrected information.The following sections were corrected: a2, b5, h11.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 a patient underwent an initial total shoulder replacement on the left side.Subsequently, approximately 1.5 years following initial replacement, the patient was being revised for unexplained pain.During the surgery, the surgeon realized that there was a humeral fracture (was not detected by imaging and other examinations).As a result, the doctor decided to remove the anatomical prosthesis and not reimplant the new one.The following day, a cerclage wire was placed around the humerus.The reverse prosthesis was reimplanted two months later after the humerus had healed.No further impact to the patient was reported.No other information is available.

• Brand Name: EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM
• Common Device Name: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19506779
• Report Number: 1038671-2024-01871
• Device Sequence Number: 15316459
• Product Code: HSD
• UDI-Device Identifier: 10885862079312
• UDI-Public: 10885862079312
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/30/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 300-01-11
• 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: 05/28/2024
• Supplement Date Received by Manufacturer: 09/11/2025; 10/24/2025; 10/24/2025
• Initial Report FDA Received Date: 06/10/2024
• Supplement Report FDA Received Date: 09/16/2025; 10/28/2025; 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• 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: 65 YR
• Patient Sex: Female
• Patient Weight: 70 KG