MAUDE Adverse Event Report: ARTHREX, INC.; SHOULDR PROSTH, REVERSE CONFIG

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Failure of Implant (1924)

Event Date 07/24/2023

Event Type  Injury  

Event Description

On (b)(6) 2023, it was reported by a sales representative via email that the trephine reamer welded the post within it.It could not be taken apart, damaging the central post/screw trephine adapter as well.This was discovered when removing the central post after the base plate was removed during a revision rtsa procedure.Additional information received on 7/26/2023: there is no known information regarding the original procedure other than it was performed in (b)(6).The patient complained of pain since the original procedure was performed.Because of this, the patient underwent revision surgery on (b)(6) 2023.Additional information received on 8/2/2023: during the revision surgery, the rtsa augmented baseplate, glenosphere and humeral stem, suture cup and insert were explanted.No further information is available.

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.

• Brand Name: UNK
• Type of Device: SHOULDR PROSTH, REVERSE CONFIG
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: emily shafer ; 8009337001
• MDR Report Key: 17631042
• MDR Text Key: 322040257
• Report Number: 1220246-2023-07585
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K221232
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 08/28/2023

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/24/2023
• Initial Date FDA Received: 08/28/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other