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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. 36 +3 / 33 COMBO HUMERAL INSERT; SHOULDER PROSTHESIS, REVERSE CONFIGURATION
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ARTHREX, INC. 36 +3 / 33 COMBO HUMERAL INSERT; SHOULDER PROSTHESIS, REVERSE CONFIGURATION Back to Search Results
Model Number 36 +3 / 33 COMBO HUMERAL INSERT
Health Effect - Clinical Code Pulmonary Embolism (1498)
Date of Event 02/24/2021
Type of Reportable Event Serious Injury
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.
 
Event or Problem Description
It was reported through the surgical outcome system that a pulmonary embolism resulting in inpatient hospitalization occurred during a shoulder arthroplasty procedure in which arthrex product was being used.The patient was treated with concomitant medication.The facility reported that the patient has been discharged from the hospital and is recovering.
 
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Brand Name
36 +3 / 33 COMBO HUMERAL INSERT
Common Device Name
SHOULDER PROSTHESIS, REVERSE CONFIGURATION
Manufacturer (Section D)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
MDR Report Key11484454
Report Number1220246-2021-02737
Device Sequence Number3804521
Product Code PHX
UDI-Device Identifier00888867296596
UDI-Public00888867296596
Combination Product (Y/N)N
Initial Reporter StateVA
Initial Reporter CountryUS
PMA/510(K) Number
K173900
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date (Section B) 03/15/2021
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 Model Number36 +3 / 33 COMBO HUMERAL INSERT
Device Catalogue NumberAR-9503-3633-3
Device Lot Number19.02681
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/24/2021
Initial Report FDA Received Date03/15/2021
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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