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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD RESURFACING FEMORAL HEAD 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
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SMITH & NEPHEW ORTHOPAEDICS LTD RESURFACING FEMORAL HEAD 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING Back to Search Results
Model Number 74121150
Device Problems Fracture (1260); Patient Device Interaction Problem (4001)
Patient Problems Bone Fracture(s) (1870); Injury (2348); No Code Available (3191)
Event Date 04/06/2020
Event Type  Injury  
Event Description
It was reported that revision surgery had to be performed due to fracture of the femoral neck.
 
Manufacturer Narrative
It was reported that a hip revision surgery was performed.As of today, the implanted devices, all of which were used in treatment, and additional information has been requested for this complaint but has not become available.A review of the complaint history for the head / cup was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other complaints have been identified for the head & cup.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.Device history record review confirmed that all released parts met specifications applicable at the time of production.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.No additional risks were identified as result of the reported event.No medical documents were received.The reported event cannot be assessed and a thorough medical assessment cannot be performed.If notification is received that additional medical documentation has been provided, this complaint will be re-evaluated and a thorough medical assessment rendered.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint, and our investigation remains inconclusive.If the products or additional information become available in the future, this case will be reopened.No preventative or corrective action has been initiated as a result of this investigation.
 
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Brand Name
RESURFACING FEMORAL HEAD 50MM
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 Key10016664
MDR Text Key189564157
Report Number3005975929-2020-00125
Device Sequence Number1
Product Code NXT
UDI-Device Identifier03596010502797
UDI-Public03596010502797
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,foreig
Type of Report Initial,Followup
Report Date 06/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/01/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number74121150
Device Catalogue Number74121150
Device Lot Number19HW00015
Was Device Available for Evaluation? No
Date Manufacturer Received06/17/2020
Patient Sequence Number1
Treatment
74120156 ACETLR CUP HAP 56MM W/ IM19EW15826.
Patient Outcome(s) Hospitalization; Required Intervention;
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