MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; GLENOID, PEGGED BETA, LARGE

Model Number	314-02-14
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	01/04/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluated by manufacturer? pending evaluation.Concomitant medical device(s): 300-01-13, (b)(4) - equinoxe, humeral stem primary, press fit 13mm; 300-10-45, (b)(4) - equinoxe replicator plate 4.5mm o/s; 300-20-02, (b)(4) - equinox square torque define screw drive kit; 310-01-47, (b)(4) - equinoxe, humeral head short, 47mm (beta).
Event or Problem Description
As reported, approximately 13 years post op the initial tsa, this patient was revised due to infection.The stem was well fixed but was not difficult to remove with slaphammer.Glenoid was loose and easily removed with cement remaining on the back of the component pegs.Patient was treated with anabiotic shoulder spacer an antibiotic beads.Patient was last known to be in stable condition.No patient information or medical history is available.
Additional Manufacturer Narrative
(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: GLENOID, PEGGED BETA, LARGE
• 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: 13333672
• Report Number: 1038671-2022-00037
• Device Sequence Number: 1673774
• Product Code: KWT
• UDI-Device Identifier: 10885862084521
• UDI-Public: 10885862084521
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2022

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 Expiration Date: 10/28/2013
• Device Model Number: 314-02-14
• Device Catalogue Number: 314-02-14
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/04/2022
• Supplement Date Received by Manufacturer: 06/25/2022
• Initial Report FDA Received Date: 01/24/2022
• Supplement Report FDA Received Date: 06/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2009
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown