MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; STEMLESS HUMERAL HEAD SHORT, 44MM (ALPHA)

Model Number 310-61-44

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Information (3190)

Event Date 08/06/2020

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.Concomitant medical device(s): 314-13-02, (b)(4), equinoxe cage glenoid small, alpha; 300-62-02, (b)(4), stemless humeral comp integrip, cage, size 2; 315-35-00, (b)(4), glnd kwire; 319-01-32, (b)(4), steinmann pin sterile 3.2mm x 178mm.

Event Description

During a procedure on this (b)(6) y/o female patient¿s left shoulder, the surgeon was revising a stemless implant 3-4 weeks post index surgery so to patient being non compliant with her rehab.Surgeon chose to convert to a reverse construct.Device is returning, patient was last known to be in stable condition following the event.

Event Description

During a procedure on this 68 y/o female patient¿s left shoulder, the surgeon was revising a stemless implant 3-4 weeks post index surgery so to patient being non compliant with her rehab.Surgeon chose to convert to a reverse construct.Reason not reported.Device is not returning, per hospital policy.Patient was last known to be in stable condition following the event.

Manufacturer Narrative

Section h10: (h3) upon review, there is no allegation against the device as the reason for revision was not reported.The most likely cause of the reported event is patient conditions.Section h11: the following sections have corrected information: (b5) description summary: during a procedure on this 68 y/o female patient¿s left shoulder, the surgeon was revising a stemless implant 3-4 weeks post index surgery so to patient being non compliant with her rehab.Surgeon chose to convert to a reverse construct.Reason not reported.Device is not returning, per hospital policy.Patient was last known to be in stable condition following the event.

• Brand Name: EQUINOXE
• Type of Device: STEMLESS HUMERAL HEAD SHORT, 44MM (ALPHA)
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10425385
• MDR Text Key: 203487253
• Report Number: 1038671-2020-00496
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862537102
• UDI-Public: 10885862537102
• Combination Product (y/n): N
• PMA/PMN Number: K173388
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 310-61-44
• Device Catalogue Number: 310-61-44
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 68 YR