MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; STEMLESS HUMERAL COMP LASER CAGE, SIZE 1

Model Number	300-60-01
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the surgeon converted a (b)(6) year old male patient from a stemless anatomic shoulder to a reverse total shoulder.Patient was revised to an equinoxe reverse shoulder glenoid plate +10mm extended cage and an equinoxe reverse shoulder glenosphere & extended locking caps 42mm, +4 offset.Patient was last known to be in stable condition following the event.Device is not returning.
Additional Manufacturer Narrative
(concomitant device(s): 310-61-50, 153399003 - stemless humeral head 50mm x 19mm x beta unknown, unknown - cage glenoid.
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 shoulder surgical revision cannot be conclusively determined; reason not reported.Section h11: the following sections have corrected information: (b5) describe event or problem: it was reported that the surgeon converted a 58 y/o male patient from a stemless anatomic shoulder to a reverse total shoulder.Patient was revised to an equinoxe reverse shoulder glenoid plate +10mm extended cage and an equinoxe reverse shoulder glenosphere & extended locking caps 42mm, +4 offset.Patient was last known to be in stable condition following the event.Device is not returning.No additional information has been provided after multiple requests/attempts.
Event or Problem Description
It was reported that the surgeon converted a 58 y/o male patient from a stemless anatomic shoulder to a reverse total shoulder.Patient was revised to an equinoxe reverse shoulder glenoid plate +10mm extended cage and an equinoxe reverse shoulder glenosphere & extended locking caps 42mm, +4 offset.Patient was last known to be in stable condition following the event.Device is not returning.No additional information has been provided after multiple requests/attempts.

• Brand Name: EQUINOXE
• Common Device Name: STEMLESS HUMERAL COMP LASER CAGE, SIZE 1
• 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: 14631222
• Report Number: 1038671-2022-00641
• Device Sequence Number: 3738756
• Product Code: KWT
• UDI-Device Identifier: 10885862559272
• UDI-Public: 10885862559272
• 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 Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2022

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: 300-60-01
• Device Catalogue Number: 300-60-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/17/2022
• Supplement Date Received by Manufacturer: 09/08/2022
• Initial Report FDA Received Date: 06/08/2022
• Supplement Report FDA Received Date: 10/01/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 89 KG