MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; HUMERAL TRAY +15MM

Model Number	320-10-15
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/27/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, this (b)(6) male patient's left shoulder was revised due to instability.Surgeon removed in-situ humeral adapter tray, liner and glenoid sphere, and replaced with larger diameter sphere and new humeral tray and poly liner.No negative outcomes after surgery.
Additional Manufacturer Narrative
Pending evaluation.
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
As reported, this (b)(6) male patient's left shoulder was revised due to instability.Surgeon removed in-situ humeral adapter tray, liner and glenoid sphere, and replaced with larger diameter sphere and new humeral tray and poly liner.No negative outcomes after surgery.
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 manufacturing issues.The cause of the subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.Section h11: the following sections have corrected information: (d1) brand name: humeral liner (d2b) common device name: prosthesis, shoulder, non-constrained, metal/polymer cemented.(d4) please disregard all info in d4, humeral liner information is unknown.(d6b) please disregard, unknown.

• Brand Name: EQUINOXE
• Common Device Name: HUMERAL TRAY +15MM
• 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: 13541734
• Report Number: 1038671-2022-00201
• Device Sequence Number: 3695967
• Product Code: KWT
• UDI-Device Identifier: 10885862086440
• UDI-Public: 10885862086440
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K082702
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2022

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 Model Number: 320-10-15
• Device Catalogue Number: 320-10-15
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/27/2022
• Supplement Date Received by Manufacturer: 08/04/2022
• Initial Report FDA Received Date: 02/16/2022
• Supplement Report FDA Received Date: 08/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2019
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male