MAUDE Adverse Event Report: EXACTECH, INC. EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-20-30
Medical Device Problem Codes	Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930)
Date of Event	08/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.D10: (b)(6), 320-10-00 - equinoxe reverse tray adapter plate.(b)(6), 300-01-11 - equinoxe, humeral stem primary, press fit 11mm.(b)(6), 315-35-00 - glnd kwire tray +0.(b)(6), 320-20-00 - eq reverse torque defining screw kit.(b)(6), 320-38-00 - equinoxe reverse 38mm humeral liner +0.(b)(6), 320-01-38 - equinoxe reverse 38mm glenosphere.(b)(6), 320-15-05 - eq rev locking screw.(b)(6), 320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm.(b)(6), 320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm.(b)(6), 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm.(b)(6), 321-20-00 - equinoxe reverse shoulder drill kit.
Event or Problem Description
As reported, approximately 4 years and 8 months post the initial right tsa, the patient was revised due to the posterior/inferior locking cap backing out and coming loose.The metal back feel out and caused infection.It was infected and the entire glenoid construct was loose and the screw broke.There was no reported surgical delay/prolongation.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
The sales record shows a quantity of 4 compression screw kits were associated with the procedure.Per the operative technique, ¿four of the six potential screw locations that will provide optimal fixation and support of the glenoid plate are identified.Primary reverse shoulders will most typically use the superior and three inferior holes based on the anatomy of the native glenoid.The two peripheral holes on the superior part of the plate are intended for revision cases in which the native glenoid bone is compromised.However, each case should be individualized and the six holes provide the surgeon with additional options to maximize fixation of the glenoid plate.¿ the review identified that there appears to be radiolucency around the screws suggestive of poor bone quality.The fracture of the screw can be seen on the explanted device.In the event of infected (septic) glenoid loosening, a compression screw remaining in uncompromised bone may be left to bear the joint load which likely resulted in the fractured screw.However, this cannot be confirmed as the devices were not returned for evaluation and evaluate the root cause of the screw breakage.Per the ifu, as part of the preoperative assessment, the surgeon must ensure that no biological, biomechanical, or other factors exist that might adversely affect the surgery and/or postoperative period.Revisions or surgical interventions are a known complication found in joint replacements.A contraindication for use is any disease state that could adversely affect the function or longevity of the implant.Additionally, if a systemic infection or a secondary remote infection is suspected or confirmed, implantation should be delayed until infection is resolved.Excessive activity and trauma affect joint replacements and can cause the failure of an implant.Only qualified surgeons knowledgably in anatomy, biomechanics, and reconstructive surgery should use these devices.The surgeon must be fully knowledgeable about all aspects of the surgical technique and use the implants in accordance with the indications and contraindications.General surgical risks include superficial or deep infections.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 1.8% for primary and 4% for reverse shoulders.The highest risk period for infection is the first two years following the surgery.There are no user-related considerations reported that appear to have contributed to the reported event.The reason for the reported revision due to infection cannot be conclusively determined; however, it may be related to an underlying patient condition.The fracture of the compression screw is most likely secondary to progressive loss of bony support around the length of the screw due to infection, consequently subjecting the tip of the compression screw to high loads resulting in the material fracture.This follow-up report is being submitted to relay corrected information.The following sections were corrected: h6 problem code.

• Brand Name: EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 20141594
• Report Number: 1038671-2024-03297
• Device Sequence Number: 3226410
• Product Code: KWS
• UDI-Device Identifier: 10885862086556
• UDI-Public: 10885862086556
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/01/2024
• Device Catalogue Number: 320-20-30
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2024
• Supplement Date Received by Manufacturer: 12/03/2024
• Initial Report FDA Received Date: 09/04/2024
• Supplement Report FDA Received Date: 12/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female