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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pulmonary Embolism (1498)
Event Date 02/24/2021
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.
 
Event 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
Type of Device
SHOULDER PROSTHESIS, REVERSE CONFIGURATION
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
vik bajnath
8009337001
MDR Report Key11484454
MDR Text Key239786951
Report Number1220246-2021-02737
Device Sequence Number1
Product Code PHX
UDI-Device Identifier00888867296596
UDI-Public00888867296596
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K173900
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 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
Device Operator 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
Initial Date Manufacturer Received 02/24/2021
Initial Date FDA Received03/15/2021
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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