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

Model Number	310-01-44
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	03/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation: concomitant device(s): screw kit 300-20-01, sn (b)(4); humeral stem 300-01-13, sn (b)(4); replicator plate 300-10-45, sn (b)(4).
Event or Problem Description
Approximately 16 months post initial tsa, the (b)(6) years old female patient presented to the surgeon with, what appeared as, an infected, loosening primary right tsa.On xray, the stem appears lose with "windshield wiper" effect.Head appears in place on xray.The patient was scoped to take biopsies for infection, which were negative.Upon scoping, it was apparent that replicator plate had dissociated from top of the stem.There was also obvious metallosis.Shoulder joint was debrided with shaver and biopsies were taken.Shoulder has not yet been revised.Patient was last known to be in stable condition following the event.The surgery on the right shoulder was completed on (b)(6) 2020.Upon opening the shoulder, the head had not dissociated from the stem.It turns out the stem was loose due to an infection.The devices will not return, the patient asked for the devices.Patient is ok except for the infection found in the procedure.
Additional Manufacturer Narrative
Section h10: (h3) based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the infection and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.

• Brand Name: EQUINOXE
• Common Device Name: HUMERAL HEAD SHORT, 44MM (ALPHA)
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9890528
• Report Number: 1038671-2020-00262
• Device Sequence Number: 2952112
• Product Code: KWT
• UDI-Device Identifier: 10885862083876
• UDI-Public: 10885862083876
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 09/24/2020

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: 310-01-44
• Device Catalogue Number: 310-01-44
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/02/2020
• Supplement Date Received by Manufacturer: 09/10/2020
• Initial Report FDA Received Date: 03/27/2020
• Supplement Report FDA Received Date: 09/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 62 YR