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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD RESURFACING FEMORAL HEAD PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

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SMITH & NEPHEW ORTHOPAEDICS LTD RESURFACING FEMORAL HEAD PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING Back to Search Results
Device Problems Material Disintegration (1177); Loose or Intermittent Connection (1371); Loss of Osseointegration (2408); Appropriate Term/Code Not Available (3191); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problems Failure of Implant (1924); Toxicity (2333); Toxicity (2333); Injury (2348)
Event Date 03/15/2019
Event Type  Injury  
Event Description

Revision surgery was performed due to femoral component loosening and elevated metal ions. Devices implanted in 2011.

 
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Brand NameRESURFACING FEMORAL HEAD
Type of DevicePROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
Manufacturer (Section D)
SMITH & NEPHEW ORTHOPAEDICS LTD
aurora house
spa park
leamington spa CV31 3HL
UK CV31 3HL
Manufacturer (Section G)
SMITH & NEPHEW ORTHOPAEDICS LTD
aurora house
spa park
leamington spa CV31 3HL
UK CV31 3HL
Manufacturer Contact
sarah freestone
MDR Report Key8427673
MDR Text Key139036708
Report Number3005975929-2019-00138
Device Sequence Number0
Product Code NXT
Combination Product (Y/N)
Reporter Country CodeUS
PMA/PMN NumberP040033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/05/2019
2 DeviceS WERE Involved in the Event: 1   2  
2 PatientS WERE Involved in the Event:1 2 
Date FDA Received03/18/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/21/2019
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 Initial

Patient TREATMENT DATA
Date Received: 03/18/2019 Patient Sequence Number: 1
Treatment
ACETABULAR CUP, PART AND LOT # UNKNOWN
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