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

Model Number GLENOSPHERE, 36MM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Joint Laxity (4526); Insufficient Information (4580)

Event Date 03/02/2023

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: serial #: (b)(4), category #: 531-78-20 - shoulder gps hex pins kit, serial #: (b)(4), category #: 308-01-08 - 8x80mm distal stem modular cemented, serial #: (b)(4), category #: 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm, serial #: (b)(4), category #: 308-10-00 - med prox body +0, serial #: (b)(4), category #: 300-21-00 - 0mm fixed angled kit, serial #: (b)(4), category #: 320-10-00 - equinoxe reverse tray adapter plate tray +0, serial #: (b)(4), category #: 320-36-03 - 145-deg pe 36mm hum liner +2.5, serial #: (b)(4), category #: 320-15-05 - eq rev locking screw, serial #: (b)(4), category #: 315-35-00 - glnd kwire, serial #: (b)(4), category #: 320-35-01 - small glenoid plate, serial #: (b)(4), category #: 308-05-22 - distal fixation ring ha 22.5, serial #: (b)(4), category #: 308-15-01 - taper locking screw 0, serial #: (b)(4), category #: 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm, serial #: (b)(4), category #: 320-20-00 - eq reverse torque defining screw kit, serial #: (b)(4), category #: tpa-13 - cement restrictor xs (extra small, sz 13), serial #: (b)(4), category #: 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm, serial #: (b)(4), category #: 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm.Additional information, including the product investigation, will be submitted within 30 days of receipt.

Event Description

It was reported that a 61 yo female patient, initial right shoulder implanted on (b)(6) 2023, was revised on (b)(6) 2023.The reason for the revision was not reported.There was a less than 30 second delay during the procedure with no patient impact as a result.The patient was last known to be in stable condition following the event.No further information.

Event Description

No implants were broken during implantation , in situ, or explantation.Patient was revised to an expanded glenosphere and constrained poly due to laxity that was discovered during post op visit.No implants are available to send back.

Event Description

Patient revised due to instability.

Manufacturer Narrative

H3: based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the instability and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.

• 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 ; 3523771140
• MDR Report Key: 16668415
• MDR Text Key: 312591267
• Report Number: 1038671-2023-00570
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862534934
• UDI-Public: 10885862534934
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180632
• 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,Followup,Followup
• Report Date: 08/16/2023

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
• Device Model Number: GLENOSPHERE, 36MM
• Device Catalogue Number: 320-31-36
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2023
• Initial Date FDA Received: 04/03/2023
• Supplement Dates Manufacturer Received: 08/16/2023; 08/16/2023
• Supplement Dates FDA Received: 08/16/2023; 08/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2021
• 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: 61 YR
• Patient Sex: Female