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

Model Number	320-46-03
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, this (b)(6) male patient's left shoulder had instability and needed a revision.Patient appeared to have shoulder "creep" and was dislocating with instability.A revision occurred and a 42 +4 glenosphere was put on with a +10 adaptor tray and 42 +0 poly.Patient was relocated in office and then dislocated again and was scheduled for a revision.No delay to surgery.Device was thrown away by hospital, unable to retrieve.
Additional Manufacturer Narrative
Pending evaluation.No information provided.
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.

• Brand Name: EQUINOXE
• Common Device Name: REVERSE 46MM HUMERAL LINER +2.5
• 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: 13451248
• Report Number: 1038671-2022-00168
• Device Sequence Number: 20335805
• Product Code: KWT
• UDI-Device Identifier: 10885862086747
• UDI-Public: 10885862086747
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2022

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: 320-46-03
• Device Catalogue Number: 320-46-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/17/2022
• Supplement Date Received by Manufacturer: 08/04/2022
• Initial Report FDA Received Date: 02/04/2022
• Supplement Report FDA Received Date: 08/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Required Intervention; Hospitalization
• Patient Age: 80 YR
• Patient Sex: Male