MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; PRESERVE STEM 8MM

Model Number	300-30-08
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant medical device(s): 320-10-00, (b)(4)- equinoxe reverse tray adapter plate tray +0.320-46-00, (b)(4) - quinoxe reverse 46mm humeral liner +0.320-01-46, (b)(4) - equinoxe reverse 46mm glenosphere.320-20-00, (b)(4) - eq reverse torque defining screw kit.
Event or Problem Description
As reported, approximately 9 mos.Postop the initial l tsa and 8mm short stem that was implanted in this (b)(6) y/o patient, came loose.The surgeon thinks the patient's stem became loose when he started playing golf.We replaced the short stem with a standard size stem and a lateralized glenosphere.Patient was last known to be in stable condition following the event.Device is not returning due to facility policy.
Additional Manufacturer Narrative
Section h10: (h3) the revision reported was likely the result of mechanical loss of fixation precipitated by forces while playing golf, leading to aseptic (non-infected) loosening.Contributions from initial fixation, bone quality, or osteolysis to the stem loosening cannot be determined from the information provided.

• Brand Name: EQUINOXE
• Common Device Name: PRESERVE STEM 8MM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11751696
• Report Number: 1038671-2021-00206
• Device Sequence Number: 3778288
• Product Code: KWT
• UDI-Device Identifier: 10885862515766
• UDI-Public: 10885862515766
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K162726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 05/20/2021

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: 300-30-08
• Device Catalogue Number: 300-30-08
• Device Lot Number: 97926008
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/12/2021
• Supplement Date Received by Manufacturer: 05/12/2021
• Initial Report FDA Received Date: 04/30/2021
• Supplement Report FDA Received Date: 05/20/2021
• 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: 88 YR
• Patient Weight: 41