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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. ECLIPSE TRUNION,43 MM TPS CTD; TOTAL SHOULDER ARTHROPLASTY SYSTEM
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ARTHREX, INC. ECLIPSE TRUNION,43 MM TPS CTD; TOTAL SHOULDER ARTHROPLASTY SYSTEM Back to Search Results
Model Number ECLIPSE TRUNION,43 MM TPS CTD
Device Problem Loose or Intermittent Connection (1371)
Patient Problem Abrasion (1689)
Event Date 10/01/2020
Event Type  malfunction  
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 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.
 
Manufacturer Narrative
Complaint not confirmed, some damaged was observed but no abnormality was found that may have contributed to the event.
 
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Brand Name
ECLIPSE TRUNION,43 MM TPS CTD
Type of Device
TOTAL SHOULDER ARTHROPLASTY SYSTEM
Manufacturer (Section D)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
MDR Report Key10786982
MDR Text Key214768894
Report Number1220246-2020-02315
Device Sequence Number1
Product Code QHQ
Combination Product (y/n)N
PMA/PMN Number
K183194
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup
Report Date 08/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/04/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberECLIPSE TRUNION,43 MM TPS CTD
Device Catalogue NumberAR-9300-43CPC
Was Device Available for Evaluation? Yes
Date Manufacturer Received10/19/2020
Patient Sequence Number1
Patient Outcome(s) Other;
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