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

Model Number	314-02-13
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant device(s): 300-01-13, 1460836 - equinoxe, humeral stem primary, press fit 13mm.300-10-45, 1254888 - equinoxe replicator plate 4.5mm o/s.300-20-02, 1507083 - equinox square torque define screw drive kit.300-20-02, 1507084 - equinox square torque define screw drive kit.310-01-50, 1424082 - equinoxe, humeral head short, 50mm (beta).
Event or Problem Description
As reported.Approximately 12 yrs postop the initial this patient was converted to a reverse shoulder yesterday.Cemented glenoid was worn extensively in the superior half with osteolysis noted on humerus and glenoid.All components were removed.Reverse shoulder was then performed.The surgeon was pleased with the extended baseplate fixation.A short stem was cemented in the humerus.Patient was left in stable condition.No additional information available.
Additional Manufacturer Narrative
Section h10: (h3) the revision reported was likely the result of wear of the glenoid component and osteolysis that developed while being implanted for approximately 12 years.However, this cannot be confirmed as the explanted devices were not returned and x-rays were not provided.

• Brand Name: EQUINOXE
• Common Device Name: GLENOID, PEGGED BETA, MEDIUM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 12266275
• Report Number: 1038671-2021-00368
• Device Sequence Number: 19960064
• Product Code: KWT
• UDI-Device Identifier: 10885862084514
• UDI-Public: 10885862084514
• 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 Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2021

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: 06/02/2014
• Device Model Number: 314-02-13
• Device Catalogue Number: 314-02-13
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/14/2021
• Supplement Date Received by Manufacturer: 10/04/2021
• Initial Report FDA Received Date: 08/03/2021
• Supplement Report FDA Received Date: 10/22/2021
• 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: Hospitalization; Required Intervention