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

Model Number	314-01-13
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
As reported, approximately 16 yrs postop the initial left tsa, this (b)(6) y/o female patient presented with profuse effusion of the left shoulder and diagnosed with aseptic glenoid loosening.The biological analysis of the liquid puncture does not find any infectious character.X-ray shows a major bone resorption around the keeled glenoid.Patient¿s glenoid component was revised.Event indicates ¿resolved¿ in the study database.Devices not returning due to study policy.
Additional Manufacturer Narrative
Section h10: (h3) the revision reported was likely the result of an insufficient bond between the bone and cement interface which led to aseptic (non-infected) loosening of the glenoid component during the 16-year period of being implanted.

• Brand Name: EQUINOXE
• Common Device Name: GLENOID, KEELED BETA, MEDIUM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11163621
• Report Number: 1038671-2021-00007
• Device Sequence Number: 13662114
• Product Code: KWT
• UDI-Device Identifier: 10885862084446
• UDI-Public: 10885862084446
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• 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): 01/28/2021

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 Model Number: 314-01-13
• Device Catalogue Number: 314-01-13
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2020
• Initial Date Received by Manufacturer: 12/16/2020
• Supplement Date Received by Manufacturer: 01/22/2021
• Initial Report FDA Received Date: 01/13/2021
• Supplement Report FDA Received Date: 01/28/2021
• 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: 61 YR
• Patient Weight: 58