MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; REV LOCKING SCREW

Model Number 320-15-05

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 05/22/2020

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Approximately 10 years postop the initial implant, the patient reported that she awoke from a nap and had pain in her left shoulder.X-rays showed that the glenosphere was dislodged from the baseplate.Intra-operative evaluation led to discovery that the reverse locking screw was broken flush with the face of the baseplate.Once screw was observed to be broken, all compression screws/locking caps were removed.Then, standard baseplate was removed & replaced with an extended cage baseplate.New compression screws were implanted, along with locking caps.A new glenosphere was implanted with a new reverse locking screw.Surgeon adjusted the humeral components to address instability.The +0 tray & 38 +0 humeral liner were replaced with a +15 tray & 38 +0 constrained liner.Shoulder was reduced & surgeon began closure.All pieces of the broken screw were recovered.Patient was last known to be in stable condition following the event.

Manufacturer Narrative

Section h10: (h3) the revision reported was likely the result of a brittle fracture associated with extreme loads acting perpendicular to the axis of the screw.The system is intended to transmit forces through the glenosphere to the glenoid plate.As previously evaluated, when the glenosphere is not fully seated, it is possible for the forces to be transmitted through the glenosphere and the locking screw, creating forces on the locking screw that cannot be supported.However, the underlying cause of the loads and subsequent fracture cannot be confirmed as the devices were not returned for evaluation.

• Brand Name: EQUINOXE
• Type of Device: REV LOCKING SCREW
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10142361
• MDR Text Key: 194762029
• Report Number: 1038671-2020-00301
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086495
• UDI-Public: 10885862086495
• Combination Product (y/n): N
• PMA/PMN Number: K063569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/02/2020

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
• Device Operator: Health Professional
• Device Model Number: 320-15-05
• Device Catalogue Number: 320-15-05
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/22/2020
• Initial Date FDA Received: 06/11/2020
• Supplement Dates Manufacturer Received: 09/14/2020
• Supplement Dates FDA Received: 10/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 76 YR