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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TANDEM BIPOLAR COCR 45OD 28ID; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
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SMITH & NEPHEW, INC. TANDEM BIPOLAR COCR 45OD 28ID; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED Back to Search Results
Model Number 71322045
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Joint Dislocation (2374)
Date of Event 04/14/2020
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that, after a thr replacement had been performed, the patient fell at some point.When the surgeon tried to reduce the dislocation of the patient, the tandem bipolar implant failed.Then, a revision surgery was perform to explant the device.The patient outcome is unknown.
 
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Brand Name
TANDEM BIPOLAR COCR 45OD 28ID
Common Device Name
PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key10045902
Report Number1020279-2020-01601
Device Sequence Number3357592
Product Code KWY
UDI-Device Identifier03596010492449
UDI-Public03596010492449
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K023743
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative,user f
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 12/10/2020
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
Operator of Device Health Professional
Device Model Number71322045
Device Catalogue Number71322045
Device Lot Number18EM03280
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 04/14/2020
Supplement Date Received by Manufacturer12/09/2020
Initial Report FDA Received Date05/12/2020
Supplement Report FDA Received Date12/10/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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