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

Model Number	310-61-44
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/06/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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 or Problem 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.
Additional 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
• Common Device Name: STEMLESS HUMERAL HEAD SHORT, 44MM (ALPHA)
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10425385
• Report Number: 1038671-2020-00496
• Device Sequence Number: 2975558
• Product Code: KWT
• UDI-Device Identifier: 10885862537102
• UDI-Public: 10885862537102
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K173388
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2020

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 Model Number: 310-61-44
• Device Catalogue Number: 310-61-44
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/06/2020
• Supplement Date Received by Manufacturer: 11/19/2020
• Initial Report FDA Received Date: 08/19/2020
• Supplement Report FDA Received Date: 11/24/2020
• 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: 68 YR