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

Model Number	320-46-03
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	06/08/2012
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: REVERSE 46MM HUMERAL LINER +2.5
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10559625
• Report Number: 1038671-2020-00530
• Device Sequence Number: 2627583
• Product Code: KWT
• UDI-Device Identifier: 10885862086747
• UDI-Public: 10885862086747
• Combination Product (Y/N): N
• Initial Reporter State: FL
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2020

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 09/01/2020
• Supplement Date Received by Manufacturer: 11/25/2020
• Initial Report FDA Received Date: 09/21/2020
• Supplement Report FDA Received Date: 12/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention