MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Erosion (1750)

Event Date 10/11/2023

Event Type  Injury  

Event Description

It was reported that a 78 yo female patient, initial left shoulder implanted on (b)(6) 2020, underwent a revision procedure on (b)(6) 2023, approximately 3 years 3 months post the initial procedure.Scapular notching was indicated.The patient was revised to a small +10mm extended cage glenoid baseplate, 36 +4mm lateralized/expanded glenosphere, +5mm humeral adaptor tray, and a 36 +0mm humeral liner.The inferior screw (34mm red) in the small glenoid baseplate broke during a patient fall and all parts and pieces were removed.There were no surgical delays reported.The patient was last known to be stable following the event.No device photos or x-rays were provided.The devices are not returning for analysis.They were taken for cultures/pathology and/or discarded by the facility.No further information.

Manufacturer Narrative

Additional information, including the product investigation, will be submitted within 30 days of receipt.

• Brand Name: EQUINOXE
• 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 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18210723
• MDR Text Key: 329031153
• Report Number: 1038671-2023-02857
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 10/27/2023
• Initial Date FDA Received: 11/27/2023
• 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: 78 YR
• Patient Sex: Female