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

Device Problem Fracture (1260)

Patient Problem Bone Fracture(s) (1870)

Event Date 02/17/2023

Event Type  Injury  

Event Description

It was reported via clinical study, that the 78 yo male patient has avn (avascular necrosis) with soft bone and while retracting for glenoid exposure the greater tuberosity fractured.The date of adverse event onset is (b)(6) 2023.The actions taken was the use of standard stem and fiber wire through tuberosity.The patient was revised by removal of components.The patient¿s outcome was last known as continuing.

Manufacturer Narrative

Section h10: (h3) upon review, there is no indication that there is a device related problem, there is no allegation against the device.The most likely cause of the reported event is related to the underlying patient condition.Section h11: *the following sections have corrected information: (b5) describe event or problem: it was reported via clinical study, that the 78 yo male patient has avn (avascular necrosis) with soft bone and while retracting for glenoid exposure the greater tuberosity fractured.The date of adverse event onset is 02-17-2023.The actions taken was the use of standard stem and fiber wire through tuberosity.The patient was revised by removal of components.The patient¿s outcome was last known as continuing.The case report form indicates this event is definitely not related to device and definitely not related to procedure.(d1) brand name: shoulder components.

Event Description

It was reported via clinical study, that the 78 yo male patient has avn (avascular necrosis) with soft bone and while retracting for glenoid exposure the greater tuberosity fractured.The date of adverse event onset is 02-17-2023.The actions taken was the use of standard stem and fiber wire through tuberosity.The patient was revised by removal of components.The patient¿s outcome was last known as continuing.The case report form indicates this event is definitely not related to device and definitely not related to procedure.

• Brand Name: SHOULDER COMPONENTS
• 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: 16628316
• MDR Text Key: 312141095
• Report Number: 1038671-2023-00521
• 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,Followup
• Report Date: 10/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2023
• 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: 09/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNK.
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 93 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White