MAUDE Adverse Event Report: EXACTECH, INC. SHOULDER-IMPLANT; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number SHOULDER - IMPLANT

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Failure of Implant (1924)

Event Date 10/10/2023

Event Type  Injury  

Manufacturer Narrative

Section d10: concomitant products: equinoxe reverse 38mm humeral liner +0 (cat# 320-38-00).+5 adapter tray.11mm stem - 38 glenosphere.4.5 x 26 screw.4.5 x 22 screw.4.5 x 30 screw.4.5 x 18 screw.Additional information, including the product investigation, will be submitted within 30 days of receipt.

Event Description

As reported, the surgeon scheduled the revision of the 74 year-old female patient shoulder approximately five years post right tsa.At some point the glenoid baseplate shifted anterior and one of the baseplate screws broke.On (b)(6) 2023 the surgeon removed the components including the broken screw.He then used an ultradrive to remove remaining cement from the humeral shaft.The surgeon replaced it with a 7mm interspace antibiotic spacer using one bag of palacos rg cement.Patient was revised to an interspace shoulder size 7mm.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Images received.The devices are not available for evaluation due to hospital kept the implants.

• Brand Name: SHOULDER-IMPLANT
• 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: kate jacobson
• MDR Report Key: 18040353
• MDR Text Key: 326980795
• Report Number: 1038671-2023-02644
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 10/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SHOULDER - IMPLANT
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/10/2023
• 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 Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female