MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE 46MM HUMERAL LINER +0; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	320-46-00
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/31/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation: concomitant device(s): 320-10-00, 05117281 - equinoxe reverse tray adapter plate tray +0.
Event or Problem Description
As reported, approximately one year post op the initial tsa, this male patient's was revised due to humeral liner disassociation.Patient was performing overhead activity 2 weeks ago and felt something in his shoulder.Presented to clinic with pain and x-ray showing possible liner disassociation.He was revised yesterday by surgeon to a new o tray and 46 mm liner of same size.No further information available.Explant is not given to rep without patient permission.Patient last known to be in stable condition.
Additional Manufacturer Narrative
Section h10: (d4) catalog number: 320-46-00, serial number: (b)(6), expiration date: 20-aug-2024, unique identifier (udi) #: (b)(4).(h3) the revision reported was likely the result of incomplete seating of the liner during implantation, bone impingement, patient-related conditions, a post traumatic event, or any combination of these possibilities, which led to humeral liner disassociation.However, this cannot be confirmed as the devices were not returned for evaluation.(h4) device manufacture date: 26-aug-2019 section h11: the following sections have corrected information: (d1) brand name: equinoxe reverse 46mm humeral liner +0 (d2b) common device name: prosthesis, shoulder, non-constrained, metal/polymer cemented.

• Brand Name: EQUINOXE REVERSE 46MM HUMERAL LINER +0
• Common Device Name: 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 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 14166459
• Report Number: 1038671-2022-00442
• Device Sequence Number: 5025035
• Product Code: KWT
• UDI-Device Identifier: 10885862086730
• UDI-Public: 10885862086730
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/20/2024
• Device Model Number: 320-46-00
• Device Catalogue Number: 320-46-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2022
• Supplement Date Received by Manufacturer: 08/09/2022
• Initial Report FDA Received Date: 04/21/2022
• Supplement Report FDA Received Date: 08/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male