MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; HUMERAL STEM PRIMARY, PRESS FIT 15MM

Model Number	300-01-15
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant device(s): 300-20-02, 2577697 - equinox square torque define screw drive kit.310-01-50, 2521261 - equinoxe, humeral head short, 50mm (beta).300-10-45, 2427659 - equinoxe replicator plate 4.5mm o/s.
Event or Problem Description
As reported, this (b)(6) y/o male patient had a right tsa with anatomic implants in (b)(6) 2013.Right side was scheduled for revision to reverse shoulder (b)(6) 1st due to pain and signs of stem loosening.The glenoid looks good on ct per surgeon.During the operation after removing the stem, the anesthesiologist requested to stop the operation if possible due to some issues.It was discussed and thought the best plan was to put a temporary spacer and leave the glenoid and postpone the full conversion to reverse until later.Today, the patient underwent removal from of the spacer which had been articulating with the caged glenoid that was left behind in place.The glenoid was still fixated well and was worn but not bad per surgeon.Revision went ¿very well¿ according to the surgeon.There is a slight chance that the hospital can release the glenoid to exactech.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
The revision reported was likely the result of both a patient-related condition and an insufficient bond between the humeral stem and the bone, which led to aseptic (non-infected) humeral stem loosening.However, this cannot be confirmed as the devices were not available for evaluation.

• Brand Name: EQUINOXE
• Common Device Name: HUMERAL STEM PRIMARY, PRESS FIT 15MM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11743896
• Report Number: 1038671-2021-00203
• Device Sequence Number: 4200020
• Product Code: KWT
• UDI-Device Identifier: 10885862079336
• UDI-Public: 10885862079336
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/17/2022
• Device Model Number: 300-01-15
• Device Catalogue Number: 300-01-15
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/09/2021
• Supplement Date Received by Manufacturer: 09/17/2021
• Initial Report FDA Received Date: 04/29/2021
• Supplement Report FDA Received Date: 10/07/2021
• 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.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Weight: 34