MAUDE Adverse Event Report: ECLIPSE CAGE SCREW M, 35MM; TOTAL SHOULDER ARTHROPLASTY SYSTEM

Model Number ECLIPSE CAGE SCREW M, 35MM

Device Problems Patient-Device Incompatibility (2682); Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Date 11/25/2020

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.If the device becomes available for evaluation, a follow-up report will be submitted.

Event Description

It was reported that 6 years after the initial surgery, a revision surgery of the eclipse with the universal glenoid was necessary as the patient suffered pain in the shoulder joint.The sub-scapularis no longer had any function.Therefore an inverse prosthesis was indicated and a prosthesis from another manufacturer was implanted.As the patient was allergic to metal, no modular conversion of the glenoid could be performed.Therefore the universal glenoid and the eclipse had to be removed.The surgeon further reported that dark traces were identified below the trunion.The lysis fringes are the result of the pe abrasion.Only small fragments of the pe insert were still present.Update 22-feb-2021: x-ray pictures and a surgery report was provided with the information that the initial surgery was performed on (b)(6) 2017.The reported event was identified on (b)(6) 2020 via scintigraphy.Update 26-feb-2021: the revision surgery was performed on (b)(6) 2021.

Manufacturer Narrative

Complaint not confirmed, no abnormality observed on the device that may have contributed to the event.The abrasion marks may have been caused by wear and tear and/or occurred during removal of the device.

• Brand Name: ECLIPSE CAGE SCREW M, 35MM
• Type of Device: TOTAL SHOULDER ARTHROPLASTY SYSTEM
• MDR Report Key: 12506385
• MDR Text Key: 272567964
• Report Number: 1220246-2021-03670
• Device Sequence Number: 1
• Product Code: QHQ
• Combination Product (y/n): N
• PMA/PMN Number: K183914
• 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: ECLIPSE CAGE SCREW M, 35MM
• Device Catalogue Number: AR-9301-02
• Device Lot Number: 16.00505
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/01/2021
• Initial Date FDA Received: 09/21/2021
• Supplement Dates Manufacturer Received: 09/01/2021
• 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