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

Catalog Number	312-01-02
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/11/2023
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 1038671-2023-02674
• Device Sequence Number: 12651510
• Product Code: HSD
• UDI-Device Identifier: 10885862248572
• UDI-Public: 10885862248572
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K131298
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/03/2023

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2023
• Initial Report FDA Received Date: 11/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/09/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 41 YR
• Patient Sex: Male
• Patient Weight: 122 KG
• Patient Race: White