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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BMHR MODULAR HEAD 54MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
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SMITH & NEPHEW ORTHOPAEDICS LTD BMHR MODULAR HEAD 54MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING Back to Search Results
Catalog Number 74432054
Device Problems Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fall (1848); Hip Fracture (2349)
Event Date 08/08/2018
Event Type  Injury  
Event Description
It was reported that the patient walked, fell over and broke the femoral neck.A revision is required.The device was not damaged.
 
Manufacturer Narrative
Smith & nephew is submitting this report pursuant to the provisions of 21cfr, part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.- attachment: [223350 summary.Pdf].
 
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Brand Name
BMHR MODULAR HEAD 54MM
Type of Device
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
Manufacturer (Section D)
SMITH & NEPHEW ORTHOPAEDICS LTD
aurora house
spa park
leamington spa CV31 3HL
UK  CV31 3HL
MDR Report Key8156026
MDR Text Key130085614
Report Number3005975929-2018-00535
Device Sequence Number1
Product Code NXT
Combination Product (y/n)N
PMA/PMN Number
P040033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 07/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number74432054
Was Device Available for Evaluation? No
Date Manufacturer Received08/09/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
BHR ACECTABULAR CUP 62, # 74120162, LOT # UNKNOWN; BMHR MODULAR STEM, # 74431314, LOT # UNKNOWN; UNKNOWN BHR DEVICE/ UNKNOWN LOT; UNKNOWN BHR DEVICE/ UNKNOWN LOT
Patient Outcome(s) Other; Required Intervention;
Patient Age44 YR
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