MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; REVERSE 46MM HUMERAL LINER +2.5

Model Number 320-46-03

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 06/08/2012

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Second revision to resolve metal allergy event was found while investigating (b)(4).K063569.Concomitant devices: 320-10-05, 2181104 - equinoxe reverse tray adapter plate tray +5; 320-15-05, 2197059 - eq rev locking screw; 320-20-00, 2218161 - eq reverse torque defining screw kit.

Manufacturer Narrative

Section h10: (h3) based on review of all available information, there is no evidence to suggest that the reported event is related to any design or the manufacturing process.The cause of the event and subsequent revision, is most likely is related to the patient¿s condition and this patient likely did not know of his allergy to metal allergy or did not report it to his surgeon.Section h11: the following sections have corrected information: (b5) describe event or problem: on (b)(6) 2011, this male patient underwent implantation of an exactech reverse total shoulder replacement.Approximately 6 months later, (b)(6)2012, the patient was revised to remove all shoulder devices containing metal to resolve a newly diagnosed metal allergy.The surgeon decided to temporarily implant devices to preserve the space and the patient¿s anatomy while the custom ceramic glenosphere implant is being manufactured.(d11) concomitant device(s): 320-10-05, 2181104 - equinoxe reverse tray adapter plate tray +5, 320-15-05, 2197059 - eq rev locking screw , 320-20-00, 2218161 - eq reverse torque defining screw kit.

Event Description

On (b)(6) 2011, this male patient underwent implantation of an exactech reverse total shoulder replacement.Approximately 6 months later, (b)(6)2012, the patient was revised to remove all shoulder devices containing metal to resolve a newly diagnosed metal allergy.The surgeon decided to temporarily implant devices to preserve the space and the patient¿s anatomy while the custom ceramic glenosphere implant is being manufactured.

• Brand Name: EQUINOXE
• Type of Device: REVERSE 46MM HUMERAL LINER +2.5
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10559625
• MDR Text Key: 207706059
• Report Number: 1038671-2020-00530
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086747
• UDI-Public: 10885862086747
• Combination Product (y/n): N
• PMA/PMN Number: K063569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/25/2016
• Device Model Number: 320-46-03
• Device Catalogue Number: 320-46-03
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention