MAUDE Adverse Event Report: EXACTECH, INC. RESURFACING CAGE, 25MM; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Catalog Number 312-01-01

Device Problem Insufficient Information (3190)

Patient Problem Failure of Implant (1924)

Event Date 03/27/2024

Event Type  Injury  

Manufacturer Narrative

H3: pending investigation.D10: 5878117 300-01-13 - equinoxe, humeral stem primary, press fit 13mm 5257931 300-10-15 - equinoxe replicator plate 1.5mm o/s 5844016 310-01-41 - equinoxe, humeral head short, 41mm (alpha).

Event Description

As reported, the 69 year old female patient had an initial right tsa on an unknown date.The surgeon determined that the patient was in need of conversion from a hemi-arthroplasty to a reverse shoulder arthroplasty.The patient was revised on (b)(6) 2024.The surgeon removed the in-situ humeral head, torque break-off screw and replicator plate, but left the existing exactech equinoxe humeral stem in place.He prepared the glenoid and implanted reverse shoulder glenoid components and implanted reverse shoulder humeral side components.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.

• Brand Name: RESURFACING CAGE, 25MM
• Type of Device: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• 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: 19149420
• MDR Text Key: 340673430
• Report Number: 1038671-2024-00914
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10885862248565
• UDI-Public: 10885862248565
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131298
• 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: 04/19/2024

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
• Device Operator: Health Professional
• Device Expiration Date: 04/18/2023
• Device Catalogue Number: 312-01-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/20/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female