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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TORNIER INC UNKNOWN TORNIER STEM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
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TORNIER INC UNKNOWN TORNIER STEM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED Back to Search Results
Catalog Number UNK_WTB
Device Problem Component Missing (2306)
Patient Problem Insufficient Information (4580)
Event Date 05/23/2022
Event Type  malfunction  
Manufacturer Narrative
There is no device to return as no device was available for procedure.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.
 
Event Description
No stock received for size 7 fracture stem.Case cancelled at point of surgery.
 
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Brand Name
UNKNOWN TORNIER STEM
Type of Device
PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
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 Key14720205
MDR Text Key295324730
Report Number0001649390-2022-00023
Device Sequence Number1
Product Code KWS
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 06/16/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNK_WTB
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 05/23/2022
Initial Date FDA Received06/16/2022
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
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