MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	320-15-03
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	05/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 2 years post op the initial left tsa, this female patient was revised due to infection.This was a suspected infection as both the glenoid baseplate and humeral stem had become loose.The patients glenoid had completely eroded so the surgeon decided to remove all implants and put a spacer in situ until the infection was cleared.Spacer was removed on (b)(6) 2022 and replaced by hemi prostheses.All implants were removed from patient.The reported event did not lead to a surgical delay/prolongation.Patient was last known to be in stable condition following the event.Devices will not be returning.
Additional Manufacturer Narrative
Pending evaluation: concomitant device(s): 320-15-05, 6409958-eq rev locking screw 321-20-00, 6433908-equinoxe reverse shoulder drill kit, 320-01-36, 6260919-36mm glenosphere 300-01-09, 6245603-equinoxe, humeral stem primary, press fit 9mm 320-20-00, 6519696-eq reverse torque defining screw kit 320-10-00, 6460789-equinoxe reverse tray adapter plate tray +0 320-36-00, 732286-36mm humeral liner +0 unconstrained.
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 surgical revision for infection cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.The most likely cause of device loosening was infection.

• Brand Name: EQUINOXE
• Common Device Name: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 14781662
• Report Number: 1038671-2022-00706
• Device Sequence Number: 14715058
• Product Code: KWT
• UDI-Device Identifier: 10885862186683
• UDI-Public: 10885862186683
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K110708
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2022

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: 320-15-03
• Device Catalogue Number: 320-15-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/02/2022
• Supplement Date Received by Manufacturer: 08/15/2022
• Initial Report FDA Received Date: 06/22/2022
• Supplement Report FDA Received Date: 09/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female