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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED GLENOSPHERE CENTERED 36 MM X 25MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
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TORNIER S.A.S. AEQUALIS REVERSED GLENOSPHERE CENTERED 36 MM X 25MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED Back to Search Results
Model Number DWD180
Device Problem Mechanical Jam (2983)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/21/2022
Event Type  malfunction  
Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
 
Event Description
It was reported that for three glenoids the central screw was blocked and could not be used in surgery.The surgeon placed an implant of another reference (eccentric glenoid because the stock of this reference was exhausted).The operation was completed successfully with an increase in operating time of 30 minutes.
 
Manufacturer Narrative
The reported event could be confirmed (jammed safety screw in the glenoid sphere before impacting) since the device was returned and was found to be in condition stated in the event description.The device inspection revealed the following: the visual inspection confirmed that the safety screw was jammed in the glenoid sphere.After loosening the safety screw, the functionality of the sphere was checked, and it could correctly impact and tighten into the baseplate-gauge without issue to report.The issue described in the reported event was unable to be reproduced.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If any additional information is provided, the investigation will be reassessed.
 
Event Description
It was reported that for three glenoids the central screw was blocked and could not be used in surgery.The surgeon placed an implant of another reference (eccentric glenoid because the stock of this reference was exhausted).The operation was completed successfully with an increase in operating time of 30 minutes.
 
Manufacturer Narrative
Please note the following correction: the establishment fda registration number was corrected from 0001649390 to 3000931034.D3 (manufacturer entity) and g1 (manufacturing site).
 
Event Description
It was reported that for three glenoids the central screw was blocked and could not be used in surgery.The surgeon placed an implant of another reference (eccentric glenoid because the stock of this reference was exhausted).The operation was completed successfully with an increase in operating time of 30 minutes.
 
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Brand Name
AEQUALIS REVERSED GLENOSPHERE CENTERED 36 MM X 25MM
Type of Device
PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
Manufacturer (Section D)
TORNIER S.A.S.
161 rue lavoisier
montbonnot saint-martin MN 38330
FR  38330
Manufacturer (Section G)
TORNIER S.A.S.
161 rue lavoisier
montbonnot saint-martin MN 38330
FR   38330
Manufacturer Contact
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key15815633
MDR Text Key304791840
Report Number0001649390-2022-00102
Device Sequence Number1
Product Code KWS
UDI-Device Identifier03700386935824
UDI-Public03700386935824
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K081059
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 09/14/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/17/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberDWD180
Device Catalogue NumberDWD180
Device Lot NumberAE1682012
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received09/07/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/19/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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