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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETABLR CUP HAP 44MM W/ IMPTR; BHR ACETABULAR CUP
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SMITH & NEPHEW ORTHOPAEDICS LTD ACETABLR CUP HAP 44MM W/ IMPTR; BHR ACETABULAR CUP Back to Search Results
Catalog Number 74120144
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fatigue (1849); Pain (1994); Discomfort (2330); Ambulation Difficulties (2544)
Event Type  Injury  
Event Description
It was reported that left hip revision surgery was performed.Patient reported discomfort, antalgia, chronic pain, altered gait, chronic fatigue.
 
Manufacturer Narrative
As of today, device return and additional information has been requested for this complaint but has not become available.Since neither the underlying medical documents nor device part details were received for investigation no thorough medical investigation, manufacturing record review and assessment of the reported event can be performed.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint.If the products or additional information become available in the future, this case will be reopened.Without additional information about this patient¿s particular case, our investigation remains inconclusive.No preventative or corrective action has been initiated as a result of this investigation.
 
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Brand Name
ACETABLR CUP HAP 44MM W/ IMPTR
Type of Device
BHR ACETABULAR CUP
Manufacturer (Section D)
SMITH & NEPHEW ORTHOPAEDICS LTD
aurora house
spa park
leamington spa, warwickshire CV31 3HL
UK  CV31 3HL
MDR Report Key8037660
MDR Text Key126106317
Report Number3005975929-2018-00422
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 consumer,foreign,other
Type of Report Initial,Followup
Report Date 04/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/05/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number74120144
Was Device Available for Evaluation? No
Date Manufacturer Received10/18/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
45-DUMMY2/HIP-DUMMY IMPLANT/UNKNOWN; 74222100/MODULAR SLEEVE -4MM 12/14/UNKNOWN; 74222138/BHR SLVD MODULAR HEAD 38MM/UNKNOWN; FEMORAL HEAD, PART AND LOT # UNKNOWN; FEMORAL HEAD, PART AND LOT # UNKNOWN
Patient Outcome(s) Hospitalization; Required Intervention;
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