MAUDE Adverse Event Report: ARTHREX, INC. ARTHREX ECLIPSE HUMERAL HEAD, 41/16; TOT ANAT SHOULDR PROSTH, UNCEM

Model Number ARTHREX ECLIPSE HUMERAL HEAD, 41/16

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Failure of Implant (1924)

Event Date 02/15/2022

Event Type  Injury  

Event Description

It was reported that a revision surgery was necessary due to a worn glenoid.It was further reported that the implant was implanted around 10 years ago in the schulthess klinik.No further information provided.

Manufacturer Narrative

H3: customer-provided photos were used for evaluation.The complaint is not confirmed based on the customer provided photos, which display an explanted arthrex eclipse¿ humeral head with no damaged observed.No change in harm was identified.

• Brand Name: ARTHREX ECLIPSE HUMERAL HEAD, 41/16
• Type of Device: TOT ANAT SHOULDR PROSTH, UNCEM
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: emily shafer ; 8009337001
• MDR Report Key: 18021923
• MDR Text Key: 326739555
• Report Number: 1220246-2023-08414
• Device Sequence Number: 1
• Product Code: QHQ
• UDI-Device Identifier: 00888867059986
• UDI-Public: 00888867059986
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K183194
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 10/27/2023

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
• Device Operator: Health Professional
• Device Model Number: ARTHREX ECLIPSE HUMERAL HEAD, 41/16
• Device Catalogue Number: AR-9341-16
• Device Lot Number: V24363
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/15/2022
• Initial Date FDA Received: 10/27/2023
• 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): Other