MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE 38MM HUMERAL LINER +0; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER

Model Number EQUINOXE REVERSE 38MM HUMERAL LINER +0

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Date 06/20/2022

Event Type  Injury  

Event Description

It was reported a (b)(6) male patient, left shoulder initially implanted on (b)(6) 2022, had greater tuberosity impingement.On (b)(6) 2022, the surgeon performed a series of releases and swapped the poly liner.Surgeon replaced the poly liner for a constrained option and increased the height.The patient was last known to be in stable condition following the event.The device is not available for return.

Manufacturer Narrative

Customer sent explanted device to bio engineering for analysis.Concomitants: 300-01-13 equinoxe, humeral stem primary, press fit 13mm- 7113985; 320-20-00 eq reverse torque defining screw kit- 7151324; 320-10-00 equinoxe reverse tray adapter plate tray +0- 7012819; 320-15-05 eq rev locking screw- 7236899; 320-01-38 equinoxe reverse 38mm glenosphere- 6818376; 320-15-07 sup/post aug plate, l rs glenoid baseplate- 5899654.

Manufacturer Narrative

H2: 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 for impingement cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.

• Brand Name: EQUINOXE REVERSE 38MM HUMERAL LINER +0
• Type of Device: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 14880992
• MDR Text Key: 295108806
• Report Number: 1038671-2022-00750
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086655
• UDI-Public: 10885862086655
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K063569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/30/2022

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: EQUINOXE REVERSE 38MM HUMERAL LINER +0
• Device Catalogue Number: 320-38-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/20/2022
• Initial Date FDA Received: 06/30/2022
• Supplement Dates Manufacturer Received: 08/22/2022
• Supplement Dates FDA Received: 09/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male