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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH AND NEPHEW, INC. SMITH AND NEPHEW, INC. IMP HEAD FEMORAL SNN BIPOLAR COBALT

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SMITH AND NEPHEW, INC. SMITH AND NEPHEW, INC. IMP HEAD FEMORAL SNN BIPOLAR COBALT Back to Search Results
Model Number 71303612
Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924); Ambulation Difficulties (2544)
Event Date 09/19/2023
Event Type  Injury  
Event Description
Presents to hospital after acute inability to ambulate on his right lower extremity.Patient further explained that on the day prior to presentation he was walking across his kitchen when he felt a snap and all of a sudden his right lower extremity collapsed from under him and was unable to bear weight afterwards.Event was completely atraumatic.Patient initially presented to an outside hospital and was noted to have failure of his right femoral implant.Patient transferred to ummc and on (b)(6)2021 underwent a revision, right total arthroplasty, hip.Femoral head explanted at 1715 description: imp head femoral snn bipolar cobalt 36mm +12 ref:(b)(4), lot: 19jm2304, expiration date: 9/27/2029, date implanted (b)(6) 2019.Stem explanted at 1800 imp stem snn high offset sz 8, ref: (b)(4), lot 13lm08143, expiration date: 11/30/2023, date implanted: (b)(6)2014.
 
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Brand Name
SMITH AND NEPHEW, INC. IMP HEAD FEMORAL SNN BIPOLAR COBALT
Type of Device
IMP HEAD FEMORAL SNN BIPOLAR COBALT
Manufacturer (Section D)
SMITH AND NEPHEW, INC.
MDR Report Key17985385
MDR Text Key327279110
Report Number17985385
Device Sequence Number1
Product Code MRA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/10/2023
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number71303612
Device Catalogue Number71303612
Device Lot Number19J M23604
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/23/2023
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age69 YR
Patient SexMale
Patient Weight104 KG
Patient EthnicityNon Hispanic
Patient RaceWhite
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