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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TORNIER INC. AEQUALIS PERFORM REVERSE SHOULDER SYSTEM; SHOULDER PROSTHESIS ECC GLENOSPHERE, 42
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TORNIER INC. AEQUALIS PERFORM REVERSE SHOULDER SYSTEM; SHOULDER PROSTHESIS ECC GLENOSPHERE, 42 Back to Search Results
Catalog Number DWJ034
Device Problems Inadequacy of Device Shape and/or Size (1583); Device Slipped (1584); Device Dislodged or Dislocated (2923)
Patient Problem Pain (1994)
Event Date 03/06/2019
Event Type  Injury  
Manufacturer Narrative
This is the final report submitted regarding this surgical event and medical device.
 
Event Description
It was reported that subject: (b)(6) underwent revision surgery to correct issues with anterosuperior escape.No other effects have been noted.
 
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Brand Name
AEQUALIS PERFORM REVERSE SHOULDER SYSTEM
Type of Device
SHOULDER PROSTHESIS ECC GLENOSPHERE, 42
Manufacturer (Section D)
TORNIER INC.
10801 nesbitt avenue s
bloomington MN 55437
Manufacturer Contact
matt kennedy
10801 nesbitt ave s
bloomington, MN 55437
9526837482
MDR Report Key8574841
MDR Text Key143869117
Report Number3004983210-2019-00014
Device Sequence Number1
Product Code PHX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K161742
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type study
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 05/01/2019
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? Yes
Device Operator Lay User/Patient
Device Catalogue NumberDWJ034
Device Lot NumberCZ1117244024
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 04/10/2019
Initial Date FDA Received05/02/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
PERFORM REV FULL WEDGE AUG BASEPLATE, 29MM
Patient Outcome(s) Required Intervention;
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