MAUDE Adverse Event Report: ARTHREX, INC. REVERS CA HUMERAL HEAD, 44/17; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Model Number	REVERS CA HUMERAL HEAD, 44/17
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/16/2021
Type of Reportable Event	Malfunction
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.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On (b)(6) 2021, it was reported by sales representative via phone that ar-9502-36arca revers 36mm ca adapter assembly (line #1) would not engage with the ar-9544-17rca revers 36mm ca adapter assembly(line # 2) the surgeon could not achieve the desired stability.A second ar-9502-36arca (line #3) was opened and the same issue occurred.The case was completed using the universal 2 stem and head system without issue.The case was delayed 45 minutes.Additional information 8/2/2021: per the sales representative, the case was on (b)(6).No additional anesthesia was required to complete the case.
Additional Manufacturer Narrative
Complaint not confirmed, the devices were found to fit with each other's properly.Cmm measurement of the taperlock features did not reveal any abnormality.

• Brand Name: REVERS CA HUMERAL HEAD, 44/17
• Common Device Name: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12335670
• Report Number: 1220246-2021-03533
• Device Sequence Number: 2695960
• Product Code: HSD
• UDI-Device Identifier: 00888867229471
• UDI-Public: 00888867229471
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K151527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2025
• Device Model Number: REVERS CA HUMERAL HEAD, 44/17
• Device Catalogue Number: AR-9544-17RCA
• Device Lot Number: 10998525
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/30/2021
• Supplement Date Received by Manufacturer: 07/30/2021
• Initial Report FDA Received Date: 08/18/2021
• Supplement Report FDA Received Date: 09/15/2021
• 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