MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; UHMWPE POST AUG GLENOID LARGE, LEFT

Model Number	314-02-24
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
As reported, this (b)(6) y/o male patient presented approximately 3 mos postop the initial l tsa for follow-up after surgery and x-rays revealed poly component was no longer in glenoid.Central peg did appear to still be in place.A pop was felt during one physical therapy appointment.Surgeon removed poly from patient via an arthroscopic and mini open technique.Glenoid became loose and free floating in joint central peg remained in patient and broke from the rest of the component.Patient has requested implant (product not returning).Pictures from procedure and pictures of removed poly are available.Patient has requested explant.Event occurred after primary surgery.No reported delay/prolongation.Device will not return due to patient requested to keep it.
Additional Manufacturer Narrative
Section h10: (h3) the revision reported may have been the result of glenoid loosening which caused the center peg to fracture and allowed the glenoid body to float free in the joint space.Possible contributing factors of the loosening/fracture may have been the result of incomplete seating of the glenoid component at the time of implantation, patient conditions, and/or abnormal forces being applied to the glenoid component during physical therapy.However, this cannot be confirmed as the device was not available for evaluation and x-ray images were not provided.Section h11: *the following sections have corrected information: (b5) describe event or problem: as reported, approximately 3 mos postop the initial ltsa, this 71 y/o male patient patient presented for follow-up after surgery and x-rays revealed poly component was no longer in glenoid.Had a failed glenoid that had been removed arthroscopically.Central peg did appear to still be in place.A pop was felt during one physical therapy appointment.Patient was last known to be in stable condition following the event.Devices will not return due to hospital policy.
Event or Problem Description
As reported, approximately 3 mos postop the initial ltsa, this 71 y/o male patient patient presented for follow-up after surgery and x-rays revealed poly component was no longer in glenoid.Had a failed glenoid that had been removed arthroscopically.Central peg did appear to still be in place.A pop was felt during one physical therapy appointment.Patient was last known to be in stable condition following the event.Devices will not return due to hospital policy.

• Brand Name: EQUINOXE
• Common Device Name: UHMWPE POST AUG GLENOID LARGE, LEFT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 12141843
• Report Number: 1038671-2021-00332
• Device Sequence Number: 11950006
• Product Code: KWT
• UDI-Device Identifier: 10885862175076
• UDI-Public: 10885862175076
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K103419
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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: 03/06/2023
• Device Model Number: 314-02-24
• Device Catalogue Number: 314-02-24
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/21/2021
• Supplement Date Received by Manufacturer: 10/04/2021
• Initial Report FDA Received Date: 07/09/2021
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 71 YR