MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; KEELED GLENOID

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Failure of Implant (1924)

Event Date 04/14/2022

Event Type  Injury  

Event Description

As reported, approximately 10 years post op the initial right tsa, this (b)(6) female patient was revised due to cuff failure and all poly keeled glenoid loosening.Converted to a reverse, original stem was well fixed.Patient was last known to be in stable condition following the event.Devices will not be retuning due to hospital policy.

Manufacturer Narrative

Pending evaluation: concomitant device(s): replicator plate and humeral head.

Manufacturer Narrative

Section h10: (h3) the revision reported was likely the result of both rotator cuff failure and aseptic glenoid loosening.The failed rotator cuff likely resulted in humeral head migration which may have led to eccentric loading and glenoid component loosening via a ¿rocking-horse phenomenon¿ and polyethylene wear/deformation.However, this cannot be confirmed as the devices were not returned for evaluation.Section h11: *the following sections have corrected information: (h6) component code: 734, bearings.

• Brand Name: EQUINOXE
• Type of Device: KEELED GLENOID
• 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: 14372062
• MDR Text Key: 291479214
• Report Number: 1038671-2022-00547
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• 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: 11/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 67 YR
• Patient Sex: Female