MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE CAGE GLENOID L, POST AUG, LEFT; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number EQUINOXE CAGE GLENOID L, POST AUG, LEFT

Device Problems Insufficient Information (3190); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Failure of Implant (1924)

Event Date 08/17/2022

Event Type  Injury  

Event Description

As reported, the patient had an initial left tsa on (b)(6) 2020.The patient had a revision due to unknown reasons and was revised to zimmer biomet reverse.The patient was last known to be in stable condition following the event.No other patient information/medical history provided.

Manufacturer Narrative

Pending investigation.

Manufacturer Narrative

H3: the revision reported was likely due to aseptic glenoid loosening secondary to ¿rocking horse effect¿ generating forces around a well-fixed center peg.The contributions from anatomic instability in the shoulder joint, misalignment of the peripheral pegs at the time of implantation, patient conditions, and/or incomplete seating of the glenoid component to the sequence of events cannot be determined as the devices were not available for evaluation and limited information was provided.D10: 300-10-15 - equinoxe replicator plate 1.5mm o/s sn: (b)(6), 300-20-02 - equinox square torque define screw drive kit sn: (b)(6), 300-30-08 - equinoxe preserve stem 8mm sn: (b)(6), 310-01-47 - equinoxe, humeral head short, 47mm (beta) sn: (b)(6), 315-35-00 - glnd kwire sn: (b)(6), 315-35-00 - glnd kwire sn: (b)(6).

• Brand Name: EQUINOXE CAGE GLENOID L, POST AUG, LEFT
• Type of Device: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15380007
• MDR Text Key: 299474719
• Report Number: 1038671-2022-01055
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 10885862200983
• UDI-Public: 10885862200983
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EQUINOXE CAGE GLENOID L, POST AUG, LEFT
• Device Catalogue Number: 314-13-24
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2019
• 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; SEE H10
• Patient Outcome(s): Required Intervention
• Patient Sex: Male