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

Model Number 314-13-22

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 03/27/2023

Event Type  Injury  

Event Description

As reported, the patient had an initial left tsa on (b)(6) 2019.The patient was revised on (b)(6) 2023.It appears as though the glenoid failed.It looks like the poly sheared off at the center peg junction.The patient was converted to a reverse shoulder.There was no reported breakage of device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.No other patient information/medical history reported.

Manufacturer Narrative

Pending investigation.D10: 5753922 300-30-08 - equinoxe preserve stem 8mm; 5975579 300-51-15 - 1.5 short fa rep plt kit; 5995798 310-01-44 - equinoxe, humeral head short, 44mm (alpha); 5941178 314-13-22 - equinoxe cage glenoid s, post aug, left; 4869279 315-35-00 - glnd kwire; 6032249 531-78-20 - shoulder gps hex pins kit.

Manufacturer Narrative

H3: the revision reported may have been the result of the center cage/center polyethylene peg detaching from the polyethylene body possibly as a result of off-axis drilling, incomplete seating of the cage glenoid during implantation, patient-related conditions, or any combination of these possibilities.However, this cannot be confirmed as the devices were not returned for evaluation, and immediate post-operative radiographs of the index surgery and pre-revision radiographs were unable to be obtained.

• Brand Name: EQUINOXE CAGE GLENOID S, POST AUG, LEFT
• Type of Device: PROSTHESIS, SHOULDER, NON-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: 16766277
• MDR Text Key: 313558805
• Report Number: 1038671-2023-00743
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862196163
• UDI-Public: 10885862196163
• 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: 09/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/27/2024
• Device Model Number: 314-13-22
• Device Catalogue Number: 314-13-22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/29/2023
• Date Manufacturer Received: 08/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2019
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female