MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; 13MM HUM STM TRL

Catalog Number	321-01-13
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant device(s): 301-01-13, 6648169 - broach 13mm *no information provided.
Event or Problem Description
As reported, the surgeon was performing a rtsa.The selected trial for the stem was a size 13.When it was time for the trials, he reduced the shoulder and thought it was too tight.He decided to redo the humeral cut.He passed the reamer, then the broaches, then the trial stem & then performed the trials once again.He again, thought it was too tight, he wanted to redo the cut again.This time he only passed the reamer size 13.He wanted to implant a final stem size 13 according to first two trials previously performed.He failed to correctly place the stem and it was stuck higher than the planned cut.The surgeon removed the size 13 stem and used a size 11 stem instead.The surgeon suspects that the exactech trial size 13 stem does not match with a 13 size definitive implant.The size 11 implant was adequate to the patient.No consequences for the patient.Devices to be returned.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
(h3) the most likely cause for the reported event is that the humerus was not reamed or broached to the correct depth or there was something in the humeral canal preventing the device from fully seating.Additional contributing factors may have been aggressive reaming of the humeral canal or hard bone which may have prevented the cortical bone from being able to compress sufficiently upon impaction of the definitive humeral stem to fully seat the implant.However, this cannot be confirmed from the provided information.

• Brand Name: EQUINOXE
• Common Device Name: 13MM HUM STM TRL
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11076063
• Report Number: 1038671-2020-00665
• Device Sequence Number: 2586407
• Product Code: LXH
• UDI-Device Identifier: 10885862086846
• UDI-Public: 10885862086846
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2021

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: 321-01-13
• Device Lot Number: 113981004
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/08/2020
• Supplement Date Received by Manufacturer: 04/29/2021
• Initial Report FDA Received Date: 12/28/2020
• Supplement Report FDA Received Date: 05/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10; SEE H10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 62 YR