MAUDE Adverse Event Report: EXACTECH, INC. UNKNOWN EQUINOXE SHOULDER COMPONENTS; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	310-62-47
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	06/20/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant device(s): 300-60-01, 295874004 -stemless humeral comp laser cage, size 1 9999 - cage glenoid.
Event or Problem Description
It was reported that this 71 y/o female patient was converted a right stemless anatomic shoulder to a reverse total shoulder.Reason for this revision was not reported.Patient was last known to be in stable condition following the event.Product is not available for return.
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; reason was not reported.Section h11: the following sections have corrected information: (b5) describe event or problem: it was reported that this 71 y/o obese female patient was converted a right stemless anatomic shoulder to a reverse total shoulder.Revision date is unknown; reason for this revision was not reported.There were no reported issues during the surgical procedure.The patient was last known to be in stable condition following the event.The product is not available for return.There has been no additional information provided after multiple attempts/requests.
Event or Problem Description
It was reported that this 71 y/o obese female patient was converted a right stemless anatomic shoulder to a reverse total shoulder.Revision date is unknown; reason for this revision was not reported.There were no reported issues during the surgical procedure.The patient was last known to be in stable condition following the event.The product is not available for return.There has been no additional information provided after multiple attempts/requests.
Additional Manufacturer Narrative
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; reason was not reported.This follow-up report is being submitted to relay corrected information.The following sections were corrected: d1, d6a, d8, g1, h6: clinical code and investigation findings.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Event or Problem Description
It was reported that this female patient was converted a right stemless anatomic shoulder to a reverse total shoulder.Revision date is unknown; reason for this revision was not reported.There were no reported issues during the surgical procedure.The patient was last known to be in stable condition following the event.The product is not available for return.There has been no additional information provided after multiple attempts/requests.

• Brand Name: UNKNOWN EQUINOXE SHOULDER COMPONENTS
• 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: geoff gannon ; 3523771140
• MDR Report Key: 15503272
• Report Number: 1038671-2022-01199
• Device Sequence Number: 5286092
• Product Code: KWT
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/23/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 310-62-47
• Device Lot Number: 295874004
• 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: 09/09/2022
• Supplement Date Received by Manufacturer: 11/01/2022; 02/14/2026
• Initial Report FDA Received Date: 09/29/2022
• Supplement Report FDA Received Date: 11/29/2022; 02/23/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 86 KG