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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR RESURFACING FEMORAL HEAD 48MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

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SMITH & NEPHEW ORTHOPAEDICS LTD BHR RESURFACING FEMORAL HEAD 48MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING Back to Search Results
Model Number 74123148
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Insufficient Information (4580)
Event Date 05/13/2022
Event Type  Injury  
Event Description
It was reported that after a bhr performed on an unknown date.The surgery failed due to unknown reasons.The bhr resurfacing femoral head 48mm was explanted.The patient current status is unknown.
 
Manufacturer Narrative
Internal complaint reference: (b)(4).
 
Manufacturer Narrative
H3, h6: it was reported that a bhr revision surgery was performed for unknown reasons.No further information has been supplied and the devices, used in treatment, were not returned for analysis.As no device batch numbers were provided for investigation for the femoral head, a manufacturing record review, device labelling / ifu review could not be performed.If more information is received, this investigation will be reopened.Without a definitive batch number, a complete review of the historical complaints data cannot be performed for the femoral head.A review of historical complaints data was performed using part numbers and the reported failure modes to evaluate patterns of repeated failures or defects in a timeframe prior 12 months as of the complaint aware date.Other similar complaints have been identified for the part number and the reported failure mode; this will continue to be monitored.A risk management review was performed.The alleged failure modes and associated risks have been anticipated within the risk file and the anticipated risk level is still adequate.A review of historic escalation actions related to the products and similar complaint events was performed.Following the review, no prior applicable escalation actions were identified.Smith and nephew has not received the explanted device and/or adequate materials to fully evaluate the complaint from a clinical perspective.If additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.Based on the information provided we cannot confirm or further investigate the reported complaint, our investigation remains inconclusive, and a definitive root cause cannot be determined.Additionally, specific factors known to contribute to the alleged fault cannot be provided due to the insufficient information.If additional information becomes available in the future, this case will be reopened.Based on this investigation, the need for corrective and preventative actions is not indicated.
 
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Brand Name
BHR RESURFACING FEMORAL HEAD 48MM
Type of Device
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
Manufacturer (Section D)
SMITH & NEPHEW ORTHOPAEDICS LTD
aurora house, spa park
leamington spa warwickshire CV31 3HL
UK  CV31 3HL
Manufacturer (Section G)
SMITH & NEPHEW ORTHOPAEDICS LTD
aurora house, spa park
leamington spa warwickshire CV31 3HL
UK   CV31 3HL
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key14599401
MDR Text Key293335953
Report Number3005975929-2022-00384
Device Sequence Number1
Product Code NXT
UDI-Device Identifier03596010552426
UDI-Public03596010552426
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P040033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 08/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/04/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number74123148
Device Catalogue Number74123148
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/19/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Hospitalization;
Patient SexMale
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