MAUDE Adverse Event Report: ARTHREX, INC. ECLIPSE TRUNION,49 MM TPS CTD; TOTAL SHOULDER ARTHROPLASTY SYSTEM

Model Number ECLIPSE TRUNION,49 MM TPS CTD

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

Patient Problems Pain (1994); Loss of Range of Motion (2032)

Event Date 12/09/2020

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 the pegged glenoid got loose after seven years.A revision surgery is necessary.Update 23-dec-2020: initial surgery took place on (b)(6) 2013.Surgery report indication: patient hat pain in the right shoulder for about three to four years with only some limited movement.The apron grip in particular is increasingly limited.The examinations including an arthro mri from (b)(6) 2012 revealed a pronounced omarthrosis with a slap lesion at a high level.The humeral head is progressively subluxating dorsally.The indication for shoulder arthroplasty is clear.Revision surgery took place on (b)(6) 2020.

Manufacturer Narrative

Complaint not confirmed, the superior surface was scratched, the cause of which is undetermined.No other abnormality observed on the device that may have contributed to the event.

• Brand Name: ECLIPSE TRUNION,49 MM TPS CTD
• Type of Device: TOTAL SHOULDER ARTHROPLASTY SYSTEM
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11841186
• MDR Text Key: 251354366
• Report Number: 1220246-2021-03082
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/22/2021

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 TRUNION,49 MM TPS CTD
• Device Catalogue Number: AR-9300-49CPC
• Device Lot Number: 11.007
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/30/2021
• Initial Date FDA Received: 05/18/2021
• Supplement Dates Manufacturer Received: 04/30/2021
• Supplement Dates FDA Received: 06/22/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other