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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TANDEM INTL BIPOLAR 46OD 28ID PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

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SMITH & NEPHEW, INC. TANDEM INTL BIPOLAR 46OD 28ID PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED Back to Search Results
Model Number 71324046
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Rupture (2208)
Event Date 12/07/2021
Event Type  Injury  
Manufacturer Narrative
Internal complaint reference (b)(4). Initial reporter name and address: postal code: (b)(6).
 
Event Description
It was reported that, after a partial arthroplasty had been performed on an unspecified date to repair a femur fracture, the patient had two consecutive falls afterwards, which caused tears in all soft tissue support structures around the hip joint. Redapt slvls mono stem 240mm sz 17 so, cocr 12/14 fem head 28 +0 and tandem intl bipolar 46od 28id were explanted. Patient outcome is unknown.
 
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Brand NameTANDEM INTL BIPOLAR 46OD 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 Key13089690
MDR Text Key282796935
Report Number1020279-2021-08858
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeSF
PMA/PMN Number
K023743
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/05/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/27/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number71324046
Device Catalogue Number71324046
Device Lot NumberR2014517
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/01/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/18/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/27/2021 Patient Sequence Number: 1
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