MAUDE Adverse Event Report: EXACTECH, INC. 36MM HUMERAL LINER +2.5MM UNCONSTRAINED; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number 320-36-03

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 11/09/2023

Event Type  Injury  

Event Description

As reported, approximately 3 months post op initial right tsa, this 64 y/o female patient was revised.Patient dislocated and became unstable.Surgeon removed the small proximal body, +5 humeral adapter tray, +2.5mm 36mm liner.To create greater stability the surgeon added a 25mm hrp middle segment, +0 proximal humeral body small, +0mm humeral adapter tray, 40mm +0 constrained humeral liner.Surgeon went from a 36mm djo glenosphere to a 40mm glenosphere.Patient was last known to be in stable condition following the event.Product not returning - hospital policy.

Manufacturer Narrative

Section h10: (h3) pending evaluation (d10) concomitant device(s): a487204 - 308-01-09 - 9x80mm distal stem modular cemented.(b)(6) - 308-05-17 - distal fixation ring ha 17.5.(b)(6) - 308-09-00 - small prox body +0.(b)(6) - 308-10-25 - 25mm middle segment modular.(b)(6) - 308-10-75 - 75mm middle segment modular.(b)(6) - 308-16-00 - taper locking screw 100.(b)(6) - 320-10-05 - equinoxe reverse tray adapter plate tray +5.(b)(6) - 320-20-00 - eq reverse torque defining screw kit.(b)(6) - 320-36-03 - 145-deg pe 36mm hum liner +2.5.

• Brand Name: 36MM HUMERAL LINER +2.5MM UNCONSTRAINED
• 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 ; 2320 nw 66 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18278680
• MDR Text Key: 329888630
• Report Number: 1038671-2023-02920
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093275
• 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
• Report Date: 12/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 320-36-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/20/2022
• 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
• Patient Age: 64 YR
• Patient Sex: Female