MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE PRESERVE STEM 10MM; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Catalog Number	300-30-10
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	12/23/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(h3) pending evaluation (d10) concomitant device(s): (b)(6) : 300-10-15 - equinoxe replicator plate 1.5mm o/s.(b)(6): 310-01-44 - equinoxe, humeral head short, 44mm (alpha).(b)(6): 314-13-02 - equinoxe cage glenoid small, alpha.(b)(6): 300-20-02 - equinox square torque define screw drive kit.
Event or Problem Description
As reported by the equinoxe shoulder study, the 73 year old female patient had an initial left tsa on (b)(6) 2018 and presented with humeral fracture, 4 year(s) and 4 month(s) post initial procedure on (b)(6) 2022.Patient slipped and fell onto left shoulder.Additional information: periprosthetic fracture at mid-portion of preserve humeral stem.The case report form indicates that this event is definitely related to the device and definitely not related to the procedure.The report also indicates that the action taken on (b)(6) 2023 was sling, no arom, and relative rest.The outcome is reported as resolved on (b)(6) 2023.Due to clinical study, no devices will be returned for evaluation.1038671-2024-00153 : 300-30-10 - equinoxe preserve stem 10mm.
Additional Manufacturer Narrative
This case previously reported in error.As there is no written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution, this event is not considered a complaint.The patient slipped and fell onto left shoulder.

• Brand Name: EQUINOXE PRESERVE STEM 10MM
• 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: miguel sosa ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18645768
• Report Number: 1038671-2024-00153
• Device Sequence Number: 15250520
• Product Code: HSD
• UDI-Device Identifier: 10885862515780
• UDI-Public: 10885862515780
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K162726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2024

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: 300-30-10
• 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: Not provided
• Supplement Date Received by Manufacturer: 02/06/2024
• Initial Report FDA Received Date: 02/05/2024
• Supplement Report FDA Received Date: 02/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2018
• 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 H10.
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 76 KG
• Patient Race: White