MAUDE Adverse Event Report: EXACTECH, INC. UHMWPE POST AUG GLENOID MEDIUM, LEFT; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number 314-02-23

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 11/19/2019

Event Type  Injury  

Event Description

It was reported by the equinoxe shoulder study that this 56 y/o male patient had a shoulder dislocation.Post op x-ray revealed shoulder was dislocated.Action taken: reduced in theatre next day.Patient was discharged in a sling on (b)(6) 2019.The case report form indicates this event is possibly related to devices and definitely related to procedure.This event report was received through clinical data collection activities.

• Brand Name: UHMWPE POST AUG GLENOID MEDIUM, LEFT
• 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: 17669421
• MDR Text Key: 322477075
• Report Number: 1038671-2023-02129
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862175069
• UDI-Public: 10885862175069
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K103419
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 314-02-23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2023
• Was Device Evaluated by Manufacturer?: No
• 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: 56 YR
• Patient Sex: Male
• Patient Weight: 86 KG
• Patient Race: White