MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; REVERSE 38MM GLENOSPHERE

Model Number 320-01-38

Device Problem Insufficient Information (3190)

Patient Problem Failure of Implant (1924)

Event Date 03/28/2022

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.Concomitant medical device(s): 320-10-05, 57850001: equinoxe reverse tray adapter plate tray +5.Unknown, unknown: 38 neutral liner.

Event Description

It was reported that a (b)(6) female patient underwent a left side revision of exactech implants, in which her reverse total shoulder was converted to a hemi shoulder.The glenoid side was removed, and 47 tall cta head and 0 replicator plate was implanted.No photos or x-rays obtained.The product is not available for return.Patient was last known to be in stable condition following the event.

Manufacturer Narrative

Lot number: 60278007, unique identifier (udi) #: (b)(4).(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 surgical revision cannot be conclusively determined; no reason provided.Section h11: the following sections have corrected information: (b5) describe event or problem: it was reported that a 75 y/o female patient underwent a left side revision of exactech implants, in which her reverse total shoulder was converted to a hemi shoulder.The glenoid side was removed, and 47 tall cta head and 0 replicator plate was implanted.No photos or x-rays obtained.The product is not available for return.Patient was last known to be in stable condition following the event.No additional information about patient or event.No additional information has been provided after multiple requests/attempts.

Event Description

It was reported that a 75 y/o female patient underwent a left side revision of exactech implants, in which her reverse total shoulder was converted to a hemi shoulder.The glenoid side was removed, and 47 tall cta head and 0 replicator plate was implanted.No photos or x-rays obtained.The product is not available for return.Patient was last known to be in stable condition following the event.No additional information about patient or event.No additional information has been provided after multiple requests/attempts.

• Brand Name: EQUINOXE
• Type of Device: REVERSE 38MM GLENOSPHERE
• 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: 14631276
• MDR Text Key: 293534015
• Report Number: 1038671-2022-00642
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086389
• UDI-Public: 10885862086389
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063569
• 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: 320-01-38
• Device Catalogue Number: 320-01-38
• Device Lot Number: 60278007
• 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: 09/30/2022
• 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): Hospitalization; Required Intervention
• Patient Age: 87 YR
• Patient Sex: Female
• Patient Weight: 75 KG