MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; REVERSE 38MM GLENOSPHERE

Model Number 320-01-38

Device Problem Fracture (1260)

Patient Problem Bone Fracture(s) (1870)

Event Date 04/20/2022

Event Type  Injury  

Manufacturer Narrative

Concomitant device(s): 300-01-13 - equinoxe, humeral stem primary, press fit 13mm; 320-38-00 - equinoxe reverse 38mm humeral liner +0; 320-10-00 - equinoxe reverse tray adapter plate tray +0; 320-15-04 - rs glenoid plate r post aug, 8 deg, right.

Event Description

As reported, this (b)(6) patient experienced a midshaft humeral fracture.Fissure of the humeral shaft during impaction of the humeral stem.Installation of 3 orthocord cerclages to strengthen the humerus weakened by the sequelae of old fracture.The case report form indicates this event is definitely not related to devices and unlikely related to procedure.This event report was received through clinical data collection activities.

Manufacturer Narrative

Section h10: d4: unique identifier (udi) #: (b)(4).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 surgical event cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition of osteonecrosis.Section h11: *the following sections have corrected information: 9b5) describe event or problem: as reported, this 53 y/o male patient at 95 kg., experienced a right midshaft humeral fracture during implant.Fissure of the humeral shaft occurred during impaction of the humeral stem.Action taken by the surgeon: installation of 3 cerclages to strengthen the humerus weakened by the sequelae of old fracture.The case report form indicates this event is definitely not related to devices and unlikely related to procedure.This event report was received through clinical data collection activities.No additional information.

Event Description

As reported, this 53 y/o male patient at 95 kg., experienced a right midshaft humeral fracture during implant.Fissure of the humeral shaft occurred during impaction of the humeral stem.Action taken by the surgeon: installation of 3 cerclages to strengthen the humerus weakened by the sequelae of old fracture.The case report form indicates this event is definitely not related to devices and unlikely related to procedure.This event report was received through clinical data collection activities.No additional information.

• Brand Name: EQUINOXE
• Type of Device: REVERSE 38MM GLENOSPHERE
• 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: 14433918
• MDR Text Key: 292036345
• Report Number: 1038671-2022-00563
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086389
• UDI-Public: 10885862086389
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K063569
• 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: 08/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 320-01-38
• Device Catalogue Number: 320-01-38
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/10/2022
• 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): Required Intervention; Hospitalization
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 95 KG