MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE PRESERVE STEM 8MM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	300-30-08
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(d10) concomitant devices: 300-30-08 - equinoxe preserve stem 8mm; 320-06-42 - glenosphere 42mm; 320-10-00 - equinoxe reverse tray adapter plate tray +0; 320-15-01 - eq rev glenoid plate; 320-15-05 - eq rev locking screw; 320-20-00 - eq reverse torque defining screw kit; 320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm; 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm; 320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm; 320-20-42 - eq rev compress screw lck cap kit, 4.5 x 42mm; 320-42-03 - 145-deg pe 42mm hum liner +2.5; 531-55-88 - ergo gps 3.2mm drill kit sterile; 531-78-20 - shouldr gps hex pins kit; a10012 - gps implant kit v2.Customer has indicated that the product is in process of being returned for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
Approximately 2 years and 8 days post initial right shoulder total arthroplasty, the patient stated he slept on his shoulder a little weird, it felt off and complained of a grinding feeling.Patient went to doctor's office for evaluation and x-rays were taken.It is observed that the poly looks to have dissociated from the tray.Patient was revised with additional notes from the doctor stating: "found that the poly had in fact dissociated from the tray and was superior to the joint.There is some wear observed on the poly.Doctor then removed the torque screw.He noted that the tray and stem had subsided a decent amount.When he went to disengage the tray from the stem, then entire construct came right out of the humerus.Some stem loosening can be observed on the x-rays.Doctor debrided the humerus and broached up on the stem.He then went on to remove the glenosphere and locking screw." there were no reported breakages or surgical delay/prolongation and the patient was last known to be in stable condition following the event.No photographs and/or radiograph images were not provided for review.Customer has indicated that the product is in process of being returned for investigation.

• Brand Name: EQUINOXE PRESERVE STEM 8MM
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 21116073
• Report Number: 1038671-2025-00169
• Device Sequence Number: 15633167
• Product Code: PHX
• UDI-Device Identifier: 10885862515766
• UDI-Public: 10885862515766
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K162726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/09/2025

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 Catalogue Number: 300-30-08
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2024
• Initial Report FDA Received Date: 01/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 74 YR
• Patient Sex: Male