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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVERS HUMERAL STEM, SIZE 7; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
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ARTHREX, INC. UNIVERS REVERS HUMERAL STEM, SIZE 7; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED Back to Search Results
Model Number UNIVERS REVERS HUMERAL STEM, SIZE 7
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
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
UNIVERS REVERS HUMERAL STEM, SIZE 7
Common Device Name
PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
Manufacturer (Section D)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
MDR Report Key11484416
Report Number1220246-2021-02736
Device Sequence Number11713423
Product Code HSD
UDI-Device Identifier00888867250390
UDI-Public00888867250390
Combination Product (Y/N)N
Initial Reporter StateVA
Initial Reporter CountryUS
PMA/510(K) Number
K161782
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 NumberUNIVERS REVERS HUMERAL STEM, SIZE 7
Device Catalogue NumberAR-9501-07P
Device Lot Number20.00845
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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