MAUDE Adverse Event Report: ARTHREX, INC.; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Pain (1994)

Event Date 04/27/2021

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.If the device becomes available for evaluation, a follow-up report will be submitted.

Event Description

It was reported that the surgeon sent an x-ray copy of a failed implanted mgs to the sales representative.The mgs implants were implanted approximately two years ago.The patient was picking up a bag of mulch and felt pain in their shoulder.The rep stated they do not have any additional details at this time, and the part/lot numbers of implanted arthrex material is currently unknown.The patient has not been in for the revision surgery.

Manufacturer Narrative

Further review of this complaint determined that this should not have been reported as a serious injury, as no serious injury occurred.

• Brand Name: UNK
• Type of Device: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11841297
• MDR Text Key: 251360573
• Report Number: 1220246-2021-03087
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• PMA/PMN Number: K173900
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 09/24/2021

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/27/2021
• Initial Date FDA Received: 05/18/2021
• Supplement Dates Manufacturer Received: 04/27/2021
• Supplement Dates FDA Received: 09/24/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other