MAUDE Adverse Event Report: EXACTECH, INC. 36MM HUMERAL LINER +0 UNCONSTRAINED; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-36-00
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	03/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3: pending investigation.D10: (b)(6) - 300-01-11 - equinoxe, humeral stem primary, press fit 11mm.(b)(6) - 315-35-00 - glnd kwire.(b)(6) - 320-10-00 - equinoxe reverse tray adapter plate tray +0.(b)(6) - 320-15-05 - eq rev locking screw.(b)(6) - 320-20-00 - eq reverse torque defining screw kit (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) - 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm.(b)(6) - 20-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm.(b)(6) - 320-31-36 - glenosphere, 36mm.(b)(6) - 320-35-01 - small glenoid plate.(b)(6) - 320-36-00 - 36mm humeral liner +0 unconstrained.(b)(6) - 321-20-00 - equinoxe reverse shoulder drill kit.
Event or Problem Description
As reported, the 77 year old female patient had an initial right tsa on (b)(6) 2023.The patient underwent a previous revision on (b)(6) 2024 (reported under 1038671-2024-00468).The patient was revised again on (b)(6) 2024 due to recurrent dislocation - assuming the second dislocation was traumatic.The stem, adapter tray, liner and glenosphere were exchanged.The glenosphere and liner were increased to 40mm and the tray was exchanged to +10 with a hope to improve the stability.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
After further review of additional information received.(h3): the cause of the patient¿s dislocation and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition as associated with the interaction between the implanted device and the patient due to patient illness, unique anatomy, or other condition that impacts the performance of the device, such as device size selection /procedure and soft tissue health and/r strength.It is a well-known device specific risk of subluxation, or dislocation.It is a known complication that a patient¿s age, weight, activity level, and/or trauma would cause the surgeon to expect early failure of the system.There is no report of device malfunction or wear.These devices are used for treatment not diagnosis.

• Brand Name: 36MM HUMERAL LINER +0 UNCONSTRAINED
• 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: matt collins ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19084562
• Report Number: 1038671-2024-00787
• Device Sequence Number: 8359216
• Product Code: KWS
• UDI-Device Identifier: 10885862086617
• UDI-Public: 10885862086617
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K093275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 07/24/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 320-36-00
• 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: 03/14/2024
• Supplement Date Received by Manufacturer: 06/11/2024
• Initial Report FDA Received Date: 04/10/2024
• Supplement Report FDA Received Date: 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2023
• 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 H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female