Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TORNIER S.A.S. AEQ REV II GLENOID BASEPLATEDIA 25 MM; SHOULDER JOINT METAL PROSTHESIS
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

TORNIER S.A.S. AEQ REV II GLENOID BASEPLATEDIA 25 MM; SHOULDER JOINT METAL PROSTHESIS Back to Search Results
Catalog Number DWD172
Device Problems Difficult to Insert (1316); Device Difficult to Setup or Prepare (1487); Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/06/2021
Event Type  malfunction  
Event Description
No connection/engagement between baseplate and glenosphere during operation.Multiple glenospheres opened but still no engagement so decision made to revise baseplate.Once baseplate revised, glenosphere engaged easily.
 
Manufacturer Narrative
The device is currently being returned.If additional information becomes available, it will be provided in a supplemental report.
 
Event Description
No connection/engagement between baseplate and glenosphere during operation.Multiple glenospheres opened but still no engagement so decision made to revise baseplate.Once baseplate revised, glenosphere engaged easily.
 
Manufacturer Narrative
Correction: please refer to d9/h3 - device not returned, h6 device code.The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.Reported lot and reference numbers of the spheres, showed that the two spheres used were different and were compatible with the first baseplate used.There was no similar complaint reported within the same baseplate lot number.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.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 the device is returned or if any additional information is provided, the investigation will be reassessed.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
AEQ REV II GLENOID BASEPLATEDIA 25 MM
Type of Device
SHOULDER JOINT METAL PROSTHESIS
Manufacturer (Section D)
TORNIER S.A.S.
161 rue lavoisier
montbonnot saint-martin 38330
FR  38330
Manufacturer (Section G)
WRIGHT MEDICAL CORK (TORNIER ORTHOPEDICS IRELAND LTD)
harnetts cross
macroom, co. cork NA
EI   NA
Manufacturer Contact
anna jusinski
161 rue lavoisier
montbonnot saint-martin 38330
FR   38330
476613500
MDR Report Key13114645
MDR Text Key285693600
Report Number3000931034-2021-00364
Device Sequence Number1
Product Code KWS
Combination Product (y/n)N
Reporter Country CodeUK
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
Report Date 03/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberDWD172
Device Lot NumberAD7675
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received02/24/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/10/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-