MAUDE Adverse Event Report: ARTHREX, INC. REVERS 36MM CA ADAPTER ASSEMBLY; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Model Number REVERS 36MM CA ADAPTER ASSEMBLY

Device Problem Failure to Advance (2524)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/16/2021

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

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.

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 36MM CA ADAPTER ASSEMBLY
• Type of Device: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12335673
• MDR Text Key: 267212131
• Report Number: 1220246-2021-03534
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 00888867230378
• UDI-Public: 00888867230378
• Combination Product (y/n): N
• PMA/PMN Number: K151527
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 09/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: REVERS 36MM CA ADAPTER ASSEMBLY
• Device Catalogue Number: AR-9502-36ARCA
• Device Lot Number: 19.02986
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other