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

Catalog Number 300-01-12

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Bone Fracture(s) (1870)

Event Date 12/07/2022

Event Type  Injury  

Event Description

It was reported via clinical study that intra-operatively the 77 yo female patient had a greater tuberosity fracture during surgery.Severely osteoporotic bone.Scarring of tuberosity from prior mini-open surgery.The action taken was orif with sutures around stem.The patient¿s outcome was last known as resolved on (b)(6) 2022.

Manufacturer Narrative

Concomitant medical products:¿ serial #: (b)(4), category#: 315-35-00 glnd kwire, serial #: (b)(4), category#: 531-55-88 ergo gps 3.2mm drill kit sterile, serial #: (b)(4), category#: 320-35-08 small superior/posterior augglenoid plate,right, serial #: (b)(4), category#: 320-20-00 eq reverse torque defining screw kit, serial #: (b)(4), category#: 531-78-20 shouldr gps hex pins kit, serial #: (b)(4), category#: 320-31-36 glenosphere, 36mm, serial #: (b)(4), category#: 320-15-05 eq rev locking screw, serial #: (b)(4), category#: 320-10-00 equinoxe reverse tray adapter plate tray +0, serial #: (b)(4), category#: 320-36-00 145-deg pe 36mm hum liner +0, serial #: (b)(4), category#: 320-20-30 eq rev compress screw lck cap kit, 4.5 x 30mm, serial #: (b)(4), category#: 320-20-26 eq rev compress screw lck cap kit, 4.5 x 26mm, serial #: (b)(4), category#: 320-20-26 eq rev compress screw lck cap kit, 4.5 x 26mm, serial #: (b)(4), category#: 320-20-30 eq rev compress screw lck cap kit, 4.5 x 30mm, additional information, including the product investigation, will be submitted within 30 days of receipt.

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 surgical revision for bone fracture cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.These devices are used for treatment not diagnosis.

• 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 66th ct.; gainesville FL 32563
• Manufacturer Contact: kate jacobson
• MDR Report Key: 16493065
• MDR Text Key: 310771095
• Report Number: 1038671-2023-00380
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862283016
• UDI-Public: 10885862283016
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 300-01-12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2021
• 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
• Treatment: SEE H10
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 69 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White