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

Catalog Number 314-13-13

Device Problems Break (1069); Fracture (1260); Positioning Problem (3009)

Patient Problems Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692)

Event Date 05/17/2019

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Doctor implanted a cage glenoid with a simpliciti stemless nucleus.He believes the poly was never fully seated and thus created a rocking horse effect generating forces that snapped the center cage.

Manufacturer Narrative

Section h10: (b2) added check for hospitalization - initial or prolonged (b5) as reported, a 62 y/o patient who weighed 73lbs, was initially implanted during a tsa (b)(6) 2016.A revision was completed on (b)(6) 2019 due to the surgeon believed the poly was never fully seated and thus created a rocking horse effect generating forces that snapped the center cage.The patient was revised to a reverse and the patient is doing well.Patient was stable as they left the or.Explants and all debris was removed from the patient.Upon review of all available information and examination of the devices, the revision reported in (b)(4) was likely the result of the caged glenoid not being fully seated at the time of implantation which ¿created a rocking horse effect generating forces that snapped the center cage (peg)¿ and cause a prosthesis fracture.The patient was revised to a reverse shoulder.(e3) occupation: physician.(g5) pma/510(k)number: k113309.(h3) the revision reported was likely the result of the caged glenoid not being fully seated at the time of implantation which ¿created a rocking horse effect generating forces that snapped the center cage (peg).¿ the patient was revised to a reverse shoulder.Section h11: corrections made in the following section(s): (section f) please disregard f6 and f8.These were entered in error.(g4) initial awareness date in initial submission should have been 16-may-2019.

• Brand Name: EQUINOXE
• Type of Device: EQUINOXE CAGE GLENOID MEDIUM, BETA
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 8659581
• MDR Text Key: 146693178
• Report Number: 1038671-2019-00317
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862172693
• UDI-Public: 10885862172693
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 314-13-13
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/16/2019
• Date Manufacturer Received: 11/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 73