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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TANDEM BIPOLAR COCR 55OD 28ID PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

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SMITH & NEPHEW, INC. TANDEM BIPOLAR COCR 55OD 28ID PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED Back to Search Results
Model Number 71322055
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Bacterial Infection (1735)
Event Date 04/09/2021
Event Type  Injury  
Event Description
It was reported that after thr surgery performed five weeks before revision surgery, the patient experienced an infection ((b)(6) bacteraemia). The revision surgery was performed on (b)(6) 2021. The following devices were explanted from the patient: cpcs ss prim so 12/14 sz 3 ((b)(4)), tandem bipolar cocr 55od 28id ((b)(4)) and cocr 12/14 fem head 28 +0 ((b)(4)). New devices were implanted. The patient outcome is unknown.
 
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Brand NameTANDEM BIPOLAR COCR 55OD 28ID
Type of DevicePROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key11781925
MDR Text Key249227624
Report Number1020279-2021-03815
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/06/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number71322055
Device Catalogue Number71322055
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/23/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 05/06/2021 Patient Sequence Number: 1
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