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

Model Number	314-02-15
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant medical products device(s): 300-01-11, 2233072 - equinoxe, humeral stem primary, press fit 11mm.310-01-44, 2012586 - equinoxe, humeral head short, 44mm (alpha).300-10-45, 2234099 - equinoxe replicator plate 4.5mm o/s.300-20-02, 2239296 - equinox square torque define screw drive kit.
Event or Problem Description
As reported, this (b)(6) male patient was raising an umbrella pain started in his left shoulder.Patient has a history of osteoarthritis and hypertension.A revision was scheduled for aseptic glenoid loosening and posterosuperior tear.The case report form indicates this event is definitely related to devices and procedure.This event report was received through clinical data collection activities.Devices will not return.
Additional Manufacturer Narrative
Section h10: (h3) the revision reported was likely the result of a rotator cuff tear and an insufficient bond between the implant and the bone, which led to aseptic (non-infected) anatomic glenoid loosening.This glenoid component was implanted for over 8 years prior to the reported glenoid loosening.However, this cannot be confirmed as the explanted devices were not returned for evaluation.

• Brand Name: EQUINOXE
• Common Device Name: GLENOID, PEGGED BETA. XLARGE
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10679115
• Report Number: 1038671-2020-00578
• Device Sequence Number: 11536823
• Product Code: KWT
• UDI-Device Identifier: 10885862084538
• UDI-Public: 10885862084538
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K093430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• 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): 10/27/2020

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 Expiration Date: 03/20/2016
• Device Model Number: 314-02-15
• Device Catalogue Number: 314-02-15
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/01/2020
• Supplement Date Received by Manufacturer: 10/14/2020
• Initial Report FDA Received Date: 10/14/2020
• Supplement Report FDA Received Date: 10/27/2020
• 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: 52 YR
• Patient Weight: 87