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

Model Number 300-60-01

Device Problem Insufficient Information (3190)

Patient Problem Failure of Implant (1924)

Event Date 05/09/2022

Event Type  Injury  

Event 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.

Manufacturer Narrative

(concomitant device(s): 310-61-50, 153399003 - stemless humeral head 50mm x 19mm x beta unknown, unknown - cage glenoid.

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 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
• Type of Device: 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
• MDR Text Key: 293532550
• Report Number: 1038671-2022-00641
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862559272
• UDI-Public: 10885862559272
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 05/17/2022
• Initial Date FDA Received: 06/08/2022
• Supplement Dates Manufacturer Received: 09/08/2022
• Supplement Dates FDA Received: 10/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 89 KG