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 04/04/2016

Event Type  Injury  

Event Description

Approximately 7 mos.Postop the initial right tsa, this (b)(6) y/o female patient experienced a scapular spine fracture (type 2) that was a fatigue fracture of the base of the acromion.The subscapularis was repaired.Gps was not used during the initial tsa.Patient¿s arm was placed in sling for 1 month.Outcome was noted as resolved (b)(6) 2016.Patient has a history of rotator cuff tear and repair.

Manufacturer Narrative

Device evaluated by manufacturer? pending evaluation.Concomitant medical device(s): 300-01-09, equinoxe, humeral stem primary, press fit 9mm; 320-38-03, equinoxe reverse 38mm humeral liner +2.5; 320-10-00, equinoxe reverse tray adapter plate tray +0; 320-15-01, eq rev glenoid plate.

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 most likely cause of the reported event was a fracture which was likely caused during implantation of the shoulder.Section h11: *the following sections have corrected information: (b5) as reported, approximately 7 mos.Postop the initial right tsa, this 80 y/o female patient experienced a scapular spine fracture (type 2) that was a fatigue fracture of the base of the acromion.The subscapularis was repaired.Gps was not used during the initial tsa.Patient¿s arm was placed in sling for 1 month.Outcome was noted as resolved 10-24-2016.Patient has a history of rotator cuff tear and repair.The case report form indicates this event is definitely not related to devices and possibly related to the procedure.This event report was received through clinical data collection activities.There are no devices to be returned due to clinical study protocol.

Event Description

As reported, approximately 7 mos.Postop the initial right tsa, this 80 y/o female patient experienced a scapular spine fracture (type 2) that was a fatigue fracture of the base of the acromion.The subscapularis was repaired.Gps was not used during the initial tsa.Patient¿s arm was placed in sling for 1 month.Outcome was noted as resolved 10-24-2016.Patient has a history of rotator cuff tear and repair.The case report form indicates this event is definitely not related to devices and possibly related to the procedure.This event report was received through clinical data collection activities.There are no devices to be returned due to clinical study protocol.

• 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: 12955071
• MDR Text Key: 281875222
• Report Number: 1038671-2021-00676
• 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: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/21/2022

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: 320-01-38
• Device Catalogue Number: 320-01-38
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/17/2021
• Initial Date FDA Received: 12/07/2021
• Supplement Dates Manufacturer Received: 04/04/2022
• Supplement Dates FDA Received: 04/21/2022
• 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
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 60 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White