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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. ARTHREX ECLIPSE HUMERAL HEAD, 43/16; TOTAL SHOULDER ARTHROPLASTY SYSTEM
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ARTHREX, INC. ARTHREX ECLIPSE HUMERAL HEAD, 43/16; TOTAL SHOULDER ARTHROPLASTY SYSTEM Back to Search Results
Model Number ARTHREX ECLIPSE HUMERAL HEAD, 43/16
Health Effect - Clinical Code Abrasion (1689)
Date of Event 10/01/2020
Type of Reportable Event Malfunction
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 that the peg glenoid ar-9105-02 became loose through abrasion.The following components are involved.Ar-9102-02 w.Batch unk; ar-9300-43cpc w.Batch 12315; ar-9301-02 w.Batch 12537; ar-9343-16 w.Batch 11295131006.Devices will be returned for investigation, therefore, revision surgery has been performed.No further information has been provided.
 
Additional Manufacturer Narrative
Complaint not confirmed, despite the marking and coating being faded, no abnormality was observed that may have contributed to the event.
 
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Brand Name
ARTHREX ECLIPSE HUMERAL HEAD, 43/16
Common Device Name
TOTAL SHOULDER ARTHROPLASTY SYSTEM
Manufacturer (Section D)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
MDR Report Key10786985
Report Number1220246-2020-02317
Device Sequence Number11497560
Product Code QHQ
UDI-Device Identifier00888867060005
UDI-Public00888867060005
Combination Product (Y/N)N
Initial Reporter CountrySZ
PMA/510(K) Number
K183194
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional,u
Initial Reporter Occupation Administrator/Supervisor
Type of Report Initial,Followup
Report Date (Section B) 08/16/2021
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 NumberARTHREX ECLIPSE HUMERAL HEAD, 43/16
Device Catalogue NumberAR-9343-16
Was Device Available for Evaluation? Yes
Initial Date Received by Manufacturer 10/19/2020
Supplement Date Received by Manufacturer10/19/2020
Initial Report FDA Received Date11/04/2020
Supplement Report FDA Received Date08/16/2021
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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