MAUDE Adverse Event Report: ARTHREX, INC. ECLIPSE TRUNION,47 MM TPS CTD; TOTAL SHOULDER ARTHROPLASTY SYSTEM

Model Number ECLIPSE TRUNION,47 MM TPS CTD

Device Problems Loose or Intermittent Connection (1371); Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 08/03/2021

Event Type  Injury  

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 a revision surgery had to be performed due to an aseptic loosening of the device.The patient was treated with a shoulder prosthesis change to an inverse shoulder prosthesis.The currently reported device is probably not correct and currently the actually affected device is still in clarification with the customer.No further information received.

• Brand Name: ECLIPSE TRUNION,47 MM TPS CTD
• Type of Device: TOTAL SHOULDER ARTHROPLASTY SYSTEM
• 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: vik bajnath ; 8009337001
• MDR Report Key: 12576397
• MDR Text Key: 274909765
• Report Number: 1220246-2021-03739
• Device Sequence Number: 1
• Product Code: QHQ
• 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: company representative,foreig
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 10/05/2021

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 Expiration Date: 03/31/2018
• Device Model Number: ECLIPSE TRUNION,47 MM TPS CTD
• Device Catalogue Number: AR-9300-47CPC
• Device Lot Number: 2501301707
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/13/2021
• Initial Date FDA Received: 10/05/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other