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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TANDEM INTL BIPOLAR 40OD 22ID PROSTHESISHIPHEMIFEMORALMETALPOLYMERCEMENTEDORUNCEMENTED

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SMITH & NEPHEW, INC. TANDEM INTL BIPOLAR 40OD 22ID PROSTHESISHIPHEMIFEMORALMETALPOLYMERCEMENTEDORUNCEMENTED Back to Search Results
Model Number 71324040
Device Problem Fitting Problem (2183)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/27/2019
Event Type  malfunction  
Event Description
It was reported that during a surgery, after the prosthesis was installed, it was found that the clasp fell off. After repeated installation and replace, the clasp still fell off. Finally a bigger size bipolar was used to complete the surgery. It is unknown if there was a delay. No injury reported.
 
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Brand NameTANDEM INTL BIPOLAR 40OD 22ID
Type of DevicePROSTHESISHIPHEMIFEMORALMETALPOLYMERCEMENTEDORUNCEMENTED
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
Manufacturer Contact
sarah freestone
1450 brooks road
memphis, TN 38116
0447940038
MDR Report Key9951743
MDR Text Key187514347
Report Number1020279-2020-01262
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K023743
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign,health profe
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/16/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/11/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number71324040
Device Catalogue Number71324040
Device Lot Number17EM20787
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/27/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/09/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/26/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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