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

Model Number 320-15-06

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Failure of Implant (1924)

Event Date 02/01/2022

Event Type  Injury  

Manufacturer Narrative

Pending evaluation: concomitant medical products: equinoxe reverse adapter plate tray +5 - 320-10-05, (b)(4).Equinoxe reverse 38mm glenosphere - 320-01-38, (b)(4).Equinoxe reverse 38mm humeral liner +2.5 - 320-38-03, (b)(4).Eq rev locking screw - 320-15-05, (b)(4).Eq reverse torque defining screw kit - 320-20-00, (b)(4).Equinoxe, humeral primary, press fit 9mm - 300-01-09, (b)(4).Eq rev compress screw lck cap kit, 4.5 x 30mm - 320-20-30, (b)(4).Eq rev compress screw lck cap kit, 4.5 x 30mm - 320-20-30, (b)(4).Eq rev compress screw lck cap kit, 4.5 x 34mm - 320-20-34, (b)(4).Eq rev compress screw lck cap kit, 4.5 x 34mm - 320-20-34, (b)(4).Eq rev compress screw lck cap kit, 4.5 x 42mm - 320-20-42, (b)(4).Eq rev compress screw lck cap kit, 4.5 x 42mm - 320-20-42, (b)(4).

Event Description

As reported, approximal 7 months post op left shoulder replacement, this (b)(6) patient was revised for a second time due to pain and instability.There was loosening of the glenoid and humeral components with implant breakage (one of the baseplate screws).Patient has poor health.Patient was last known to be in stable condition following the event.Surgeon was happy with the revision result.Devices will not be retuning due to the hospital disposing of them.

Manufacturer Narrative

(h3) the revision reported was likely the result of insufficient fixation between the implants and the bones and patient-related conditions, including multiple procedures/revisions on the involved shoulder, which led to aseptic (non-infected) humeral and glenoid loosening and subsequent compression screw fracture.However, this cannot be confirmed as the devices were not available for evaluation.Section h11: the following sections have corrected information: (h6) medical device problem code: 4002, loosening of implant not related to bone-ingrowth component code: 568, screw.

• 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: 13580971
• MDR Text Key: 289513698
• Report Number: 1038671-2022-00214
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862186706
• UDI-Public: 10885862186706
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K063569
• 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: 08/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2022
• 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: 07/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2019
• 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): Required Intervention; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Female