MAUDE Adverse Event Report: ARTHREX ECLIPSE HUMERAL HEAD, 47/18; TOTAL SHOULDER ARTHROPLASTY SYSTEM

Model Number ARTHREX ECLIPSE HUMERAL HEAD, 47/18

Device Problem Material Fragmentation (1261)

Patient Problems Hypersensitivity/Allergic reaction (1907); Implant Pain (4561)

Event Date 01/29/2021

Event Type  malfunction  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.

Event Description

It was reported that 6 years after the initial surgery in the schulthess klinik a revision surgery of the eclips with the universal glenoid was necessary as the patient suffered pain in the shoulder joint.The subscapularis no longer had any function.Therefore an inverse prosthesis was indicated and a prothesis from another manufactuerer was implanted.As the patient was allergic to metal no modulare conversion of the glenoid could be performed.Therefore the universal glenoid and the eclipse had to be removed.The surgeon further reporetd that dark traces were identified below the trunion.Theses lysis fringes are the result of the pe abrasion.Only small fragments of the pe insert were still present.

Manufacturer Narrative

Complaint not confirmed, no abnormality observe don the device that may have contributed to the event.The abrasion marks on the surface mating with the stem likely occurred during removal of the device.The worn spherical surface is likely a result of wear and tear.

• Brand Name: ARTHREX ECLIPSE HUMERAL HEAD, 47/18
• Type of Device: TOTAL SHOULDER ARTHROPLASTY SYSTEM
• MDR Report Key: 11357661
• MDR Text Key: 232801017
• Report Number: 1220246-2021-02599
• Device Sequence Number: 1
• Product Code: QHQ
• Combination Product (y/n): N
• PMA/PMN Number: K183194
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 11/02/2021

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, 47/18
• Device Catalogue Number: AR-9347-18
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/01/2021
• Initial Date FDA Received: 02/22/2021
• Supplement Dates Manufacturer Received: 02/01/2021
• Supplement Dates FDA Received: 11/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other