MAUDE Adverse Event Report: ARTHREX, INC. ARTHREX ECLIPSE HUMERAL HEAD, 49/18; TOTAL SHOULDER ARTHROPLASTY SYSTEM

Model Number ARTHREX ECLIPSE HUMERAL HEAD, 49/18

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Joint Dislocation (2374)

Event Date 07/14/2020

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.

Event Description

It was reported that the patient underwent a total shoulder arthroplasty using the eclipse system on (b)(6) 2020.Upon review of the post operative x-ray, on post-op day 1, it was noticed that the shoulder was dislocated.A second x-ray was performed the same day and it was confirmed that the shoulder was in fact dislocated.The patient was not able to remember when or how the shoulder may have dislocated.A revision tsa-humeral head exchange surgery was scheduled and performed on (b)(6) 2020 (post-op day 1).It was noted during the revision that the subscapularis repair was still in tact but had to be taken down to get the shoulder relocated.After the shoulder was relocated the eclipse humeral head, ar-9349-18 (lot 18.0147) was removed and the entire shoulder joint was evaluated for any possible problem.The surgeon then proceeded to trial three different humeral head sizes and settled on the most stable humeral head which was an ar-9349-20 (lot 1735002).A speedbridge technique was performed to repair the subscapularis.

Manufacturer Narrative

Complaint not confirmed, no abnormality was found on the device that may have contributed to the event.The cause is undetermined.

• Brand Name: ARTHREX ECLIPSE HUMERAL HEAD, 49/18
• Type of Device: TOTAL SHOULDER ARTHROPLASTY SYSTEM
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10333402
• MDR Text Key: 200775194
• Report Number: 1220246-2020-01981
• Device Sequence Number: 1
• Product Code: QHQ
• UDI-Device Identifier: 00888867060067
• UDI-Public: 00888867060067
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 08/13/2020

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: 02/29/2024
• Device Model Number: ARTHREX ECLIPSE HUMERAL HEAD, 49/18
• Device Catalogue Number: AR-9349-18
• Device Lot Number: 18.01427
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/16/2020
• Initial Date FDA Received: 07/28/2020
• Supplement Dates Manufacturer Received: 07/16/2020
• Supplement Dates FDA Received: 08/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other