MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE 42MM GLENOSPHERE; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number 320-01-42

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Radiation Burn (1755)

Event Date 03/20/2023

Event Type  Injury  

Event Description

As reported, approximately 6 months post op the initial left tsa, this 66 y/o male patient was revised due infection.No breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.No other patient information/medical history reported.Photos attached, unable to obtain x-rays.Product not returning - surgeon took it.

Manufacturer Narrative

Device pending evaluation.Concomitant device(s): a128631 300-01-11 - equinoxe, humeral stem primary, press fit 11mm; a046605 320-10-00 - equinoxe reverse tray adapter plate tray +0; 7295094 320-15-01 - eq rev glenoid plate; a117518 320-15-05 - eq rev locking screw; a122310 320-20-00 - eq reverse torque defining screw kit; a156946 320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm; a157078 320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm; s368394 320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm; a118401 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm; a141088 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm; a123385 320-42-00 - equinoxe reverse 42mm humeral liner +0; 6929600 321-20-00 - equinoxe reverse shoulder drill kit; a010819 321-52-09 - 3.2mm k-wire, trocar tip; a010928 321-52-09 - 3.2mm k-wire, trocar tip.

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 infection and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.

• Brand Name: EQUINOXE REVERSE 42MM GLENOSPHERE
• Type of Device: 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: kate jacobson ; 3523771140
• MDR Report Key: 16723646
• MDR Text Key: 313167252
• Report Number: 1038671-2023-00655
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086396
• UDI-Public: 10885862086396
• 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: 07/06/2023

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 Catalogue Number: 320-01-42
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/23/2023
• Initial Date FDA Received: 04/12/2023
• Supplement Dates Manufacturer Received: 06/15/2023
• Supplement Dates FDA Received: 07/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2022
• 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 Age: 66 YR
• Patient Sex: Male
• Patient Weight: 120 KG