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

Model Number	ARTHREX ECLIPSE HUMERAL HEAD, 49/18
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	07/14/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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
• Common Device Name: TOTAL SHOULDER ARTHROPLASTY SYSTEM
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10333402
• Report Number: 1220246-2020-01981
• Device Sequence Number: 3749379
• Product Code: QHQ
• UDI-Device Identifier: 00888867060067
• UDI-Public: 00888867060067
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K183194
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 07/16/2020
• Supplement Date Received by Manufacturer: 07/16/2020
• Initial Report FDA Received Date: 07/28/2020
• Supplement Report FDA Received Date: 08/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other