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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC.; SHOULDR PROSTH, REVERSE CONFIG
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ARTHREX, INC.; SHOULDR PROSTH, REVERSE CONFIG Back to Search Results
Device Problem Patient Device Interaction Problem (4001)
Patient Problem Bone Fracture(s) (1870)
Event Date 11/07/2023
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
On (b)(6), 2023, a clindex notification was received indicating that a severe complication occurred to a patient listed on the shoulder arthroplasty registry.The patient suffered bone fractures in the targeted shoulder, which required surgical intervention.The patient had the original surgery on (b)(6) 2018 in which the univers revers apex system was implanted.No further information was provided.
 
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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 Key18278532
MDR Text Key329890567
Report Number1220246-2023-09244
Device Sequence Number1
Product Code PHX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Study,Health Professional,User Facility
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 12/06/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/06/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received11/07/2023
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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