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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TORNIER INC AEQUALIS PERFORM REVERSED; SHOULDER PROSTHESIS, REVERSE CONFIGURATION
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TORNIER INC AEQUALIS PERFORM REVERSED; SHOULDER PROSTHESIS, REVERSE CONFIGURATION Back to Search Results
Model Number DWJ024
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Joint Dislocation (2374)
Event Date 08/27/2018
Event Type  Injury  
Manufacturer Narrative
Neither the device nor applicable imaging films were returned to the manufacturer for evaluation, therefore, the cause of the event cannot be determined.
 
Event Description
Allegedly, the patient had instability and dislocation of the glenosphere with no associated injury.The patient underwent a revision surgery and the device was explanted.
 
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Brand Name
AEQUALIS PERFORM REVERSED
Type of Device
SHOULDER PROSTHESIS, REVERSE CONFIGURATION
Manufacturer (Section D)
TORNIER INC
10801 nesbitt avenue s
bloomington MN 55437
Manufacturer (Section G)
TORNIER INC
10801 nesbitt avenue s
bloomington MN 55437
Manufacturer Contact
andrew melchiori
1023 cherry rd
memphis, TN 38117
MDR Report Key10935407
MDR Text Key219187246
Report Number3004983210-2020-00046
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 company representative,health
Reporter Occupation Other
Type of Report Initial
Report Date 11/04/2020
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 Health Professional
Device Model NumberDWJ024
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/04/2020
Initial Date FDA Received12/02/2020
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
Patient Outcome(s) Required Intervention;
Patient Age74 YR
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