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 INC TORNIER SIMPLICITI NUCLEUS SIZE 3; PROSTHESIS, TOTAL ANATOMIC SHOULDER, UNCEMENTED METAPHYSEAL HUMERAL STEM WITH NO
  • 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 INC TORNIER SIMPLICITI NUCLEUS SIZE 3; PROSTHESIS, TOTAL ANATOMIC SHOULDER, UNCEMENTED METAPHYSEAL HUMERAL STEM WITH NO Back to Search Results
Catalog Number DWG403
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Insufficient Information (4580)
Event Date 10/31/2023
Event Type  Injury  
Event Description
A revision surgery took place where a tornier simpliciti hemi-implant was replaced with a perform humeral in-lay reverse implant.The original implants removed were a tornier simpliciti size 3 nucleus and a simpliciti anatomic head, with an unknown date of initial implantation.The reason for the revision surgery was not specified.
 
Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided on a supplemental report.H3 other text : device disposition unknown.
 
Event Description
A revision surgery took place where a tornier simpliciti hemi-implant was replaced with a perform humeral in-lay reverse implant.The original implants removed were a tornier simpliciti size 3 nucleus and a simpliciti anatomic head, with an unknown date of initial implantation.The reason for the revision surgery was not specified.
 
Manufacturer Narrative
The reported event was not confirmed, since the device was not returned for evaluation and based on x-rays provided a formal medical opinion was sought and following is concluded: ¿looking at the x-rays there as several possible reasons for the revision indication.Without clinical information it is difficult to assess the status of the complete rc, but progression of rc degeneration is a possible indication.Another reason could be erosion of the native glenoid.There is some erosion in this case, albeit clinical information is needed to assess whether this is clinically relevant.¿ the device inspection was not possible as the product was not returned for investigation.The device history record could not be reviewed because the affected device was not returned, and the lot number was not communicated.A review of the labeling did not indicate any abnormalities.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.If device is returned or any further information is provided, the investigation report will be reassessed.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
TORNIER SIMPLICITI NUCLEUS SIZE 3
Type of Device
PROSTHESIS, TOTAL ANATOMIC SHOULDER, UNCEMENTED METAPHYSEAL HUMERAL STEM WITH NO
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
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key18484377
MDR Text Key332559094
Report Number0001649390-2024-00013
Device Sequence Number1
Product Code PKC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K143552
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/21/2024
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? No
Device Operator Lay User/Patient
Device Catalogue NumberDWG403
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/15/2023
Initial Date FDA Received01/10/2024
Supplement Dates Manufacturer Received02/09/2024
Supplement Dates FDA Received02/21/2024
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 SexMale
-
-