MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE 42MM HUMERAL LINER +0; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number EQUINOXE REVERSE 42MM HUMERAL LINER +0

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

Patient Problem Unspecified Infection (1930)

Event Date 02/22/2024

Event Type  Injury  

Event Description

As reported, approximately one year post initial right tsa, the 59 y/o male patient presented with an infection.The equinoxe reverse was taken out and an antibiotic spacer was put back in.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Images received.Sales rep was unable to obtain x-rays.The devices are no available for evaluation due to they were discarded.

Manufacturer Narrative

Section d10: concomitant products - equinoxe reverse tray adapter plate tray +0 (cat# 320-10-00 / serial# (b)(6).- eq rev compress screw lck cap kit, 4.5 x 18mm (cat# 320-20-18 / serial# (b)(6).- eq rev compress screw lck cap kit, 4.5 x 34mm (cat# 320-20-34 / serial# (b)(6).- eq rev glenoid plate (cat# 320-15-01 / serial# (b)(6).- eq reverse torque defining screw kit (cat# 320-20-00 / serial# (b)(6).- equinoxe reverse 42mm glenosphere (ca# 320-01-42 / serial# (b)(6).- equinoxe, humeral stem primary, press fit 13mm (cat# 300-01-13 / serial#(b)(6).- eq rev compress screw lck cap kit, 4.5 x 18mm (cat# 320-20-18 / serial# (b)(6).- eq rev locking screw (cat# 320-15-05 / serial# (b)(6).Additional information, including the product investigation, will be submitted within 30 days of receipt.

Manufacturer Narrative

H3: infection is a clinically well-known potential complication of any surgical procedure including shoulder arthroplasty.If infection occurs after shoulder replacement, whether related to the procedure or otherwise, the foreign metal and plastic implants can serve as a surface for the bacteria to latch onto, inaccessible to antibiotics.Even if the implants remain well fixed, the pain, swelling, and drainage from the infection make the revision surgery necessary.With current surgical techniques and antibiotic regimens, the rate of infection following shoulder replacement is (b)(4) for primary and (b)(4) for reverse shoulders.(1) the highest risk period for infection is the first two years following the surgery.(1, 2) 1.J.S.Coste, s.Reig, c.Trojani, m.Berg, g.Walch, p.Boileau.¿the management of infection in arthroplasty of the shoulder¿.The journal of bone and joint surgery (br).January 2004; 86-b: 65-9.2.W.Zimmerli, a.Trampuz, p.E.Ochsner."prosthetic-joint infections".The new england journal of medicine.October 2004; 351:1645-54.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.

• Brand Name: EQUINOXE REVERSE 42MM HUMERAL LINER +0
• 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 court; gainesville FL 32653
• Manufacturer Contact: michael crader
• MDR Report Key: 18919052
• MDR Text Key: 337843433
• Report Number: 1038671-2024-00530
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086693
• UDI-Public: 10885862086693
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/22/2024

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 42MM HUMERAL LINER +0
• Device Catalogue Number: 320-42-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/22/2024
• Initial Date FDA Received: 03/16/2024
• Supplement Dates Manufacturer Received: 08/16/2024
• Supplement Dates FDA Received: 08/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2023
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male