MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; RS GLENOID PLATE EXT CAG +10MM CAGE PEG

Model Number 320-15-06

Device Problem Insufficient Information (3190)

Patient Problem Failure of Implant (1924)

Event Date 12/27/2018

Event Type  Injury  

Event Description

It was reported that approximately 8 months post op the initial tsa, this 57 y/o male patient was revised for unknown reasons.This was discovered while investigating case-2022-00004984 (1038671-2022-00221 and 1038671-2022-00222).

Manufacturer Narrative

Concomitant device: 300-01-11, (b)(4) - equinoxe, humeral stem primary, press fit 11mm.320-01-42, (b)(4) - equinoxe reverse 42mm glenosphere.320-10-05, (b)(4)- equinoxe reverse tray adapter plate tray +5.320-15-05, (b)(4) - eq rev locking screw.320-15-06, (b)(4) - rs glenoid plate ext cag +10mm cage peg.320-20-00, (b)(4) - eq reverse torque defining screw kit.320-20-18, (b)(4) - eq rev compress screw lck cap kit, 4.5 x 18mm.320-20-26, (b)(4) - eq rev compress screw lck cap kit, 4.5 x 26mm.320-20-38, (b)(4) - eq rev compress screw lck cap kit, 4.5 x 38mm.320-42-00, (b)(4) - equinoxe reverse 42mm humeral liner +0.Tpa-13, (b)(4) - cement restrictor xs (extra small, sz 13).

Manufacturer Narrative

Section h10: (h3) based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of surgical revision cannot be conclusively determined; reason not provided.Section h11: *the following sections have corrected information: (b5) describe event or problem: it was reported that approximately 8 months post op the initial tsa, this 57 y/o male patient was revised for unknown reasons.This was discovered while investigating (b)(4) (1038671-2022-00221 and 1038671-2022-00222).Implants were not available to be returned due to hospital policy.No additional information has been provided after multiple attempts.

Event Description

It was reported that approximately 8 months post op the initial tsa, this 57 y/o male patient was revised for unknown reasons.This was discovered while investigating case-2022-00004984 (1038671-2022-00221 and 1038671-2022-00222).Implants were not available to be returned due to hospital policy.No additional information has been provided after multiple attempts.

• Brand Name: EQUINOXE
• Type of Device: RS GLENOID PLATE EXT CAG +10MM CAGE PEG
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 14763540
• MDR Text Key: 295047400
• Report Number: 1038671-2022-00698
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862186706
• UDI-Public: 10885862186706
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110708
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 320-15-06
• Device Catalogue Number: 320-15-06
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male