MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; EQUINOXE, HUMERAL HEAD EXPANDED, 53MM (BETA)

Model Number	310-03-53
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	05/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant device: 300-51-45, 3878853 - 4.5 short fa rep plt kit.
Event or Problem Description
As reported, after approximately 2.5 months postop from the antibiotic spacer placement, concern for infection was gone, the patient and surgeon decided to revise to a reverse tsa for better function due to rotator cuff deficiency.A reverse was implanted retained the original stem.The patient was brought through a satisfactory and stable range of motion and the procedure was completed.The patient left the operating room stable and the surgeon expects a good outcome.Devices will not return due to hospital policy.
Additional Manufacturer Narrative
It has been determined that this event is related to fda number 1038671-2020-00228.Please see 1038671-2020-00228 for additional information regarding this case.

• Brand Name: EQUINOXE
• Common Device Name: EQUINOXE, HUMERAL HEAD EXPANDED, 53MM (BETA)
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10220730
• Report Number: 1038671-2020-00330
• Device Sequence Number: 16952220
• Product Code: HSD
• UDI-Device Identifier: 10885862083999
• UDI-Public: 10885862083999
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2020

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: 310-03-53
• Device Catalogue Number: 310-03-53
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/06/2020
• Supplement Date Received by Manufacturer: 05/06/2020
• Initial Report FDA Received Date: 07/01/2020
• Supplement Report FDA Received Date: 07/08/2020
• 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: Required Intervention
• Patient Age: 80 YR