MAUDE Adverse Event Report: EXACTECH, INC. RESURFACING CAGE, 30MM; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Catalog Number 312-01-02

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Failure of Implant (1924)

Event Date 10/11/2023

Event Type  Injury  

Event Description

As reported, the patient had an initial right tsa on (b)(6) 2018.The patient presented on (b)(6) 2023 and not ae.Patient just has gle glenoid wear the patient was revised on (b)(6) 2023.The case report form indicates that this event is possibly related to device, possibly related to procedure.Outcome: continuing.

Manufacturer Narrative

Pending investigation.D10: 5240744 313-35-00 - 3mm x 250mm k-wire.5284720 312-01-50 - resurfacing humeral head 50mm.

• Brand Name: RESURFACING CAGE, 30MM
• 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: kate jacobson ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18065746
• MDR Text Key: 327290384
• Report Number: 1038671-2023-02674
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10885862248572
• UDI-Public: 10885862248572
• 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: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/07/2022
• Device Catalogue Number: 312-01-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/24/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/09/2017
• 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
• Treatment: SEE H10.
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR
• Patient Sex: Male
• Patient Weight: 122 KG
• Patient Race: White