SMITH & NEPHEW ORTHOPAEDICS LTD RESURFACING FEMORAL HEAD 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
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Model Number 74121150 |
Device Problems
Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Metal Related Pathology (4530)
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Event Date 01/11/2019 |
Event Type
Injury
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Manufacturer Narrative
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Complaint reference: case-(b)(4).
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Event Description
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It was reported that the patient underwent medically-indicated revision of the bhr left hip implants on (b)(6) 2019.The revision surgery was performed due to severe pain, failed left hip resurfacing, stiffness, loss of mobility, and metallosis.The patient outcome is unknown.
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Manufacturer Narrative
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It was reported that left hip revision surgery was performed.As of today, the implanted devices, all of which were used in treatment, and additional information have been requested for this complaint but have not become available.As no device batch numbers were provided for investigation, a complaint history review, manufacturing record review and device labelling/ifu review could not be performed.If more information is received, this investigation will be reopened.A risk management review was performed.No additional risks were identified as result of the reported event and no further actions are required at this time.Smith and nephew has not received the device/adequate materials to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.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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Manufacturer Narrative
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It was reported that left hip revision surgery was performed.During the revision, the bhr cup and bhr head were removed.As of today, the implanted devices, all of which were used in treatment, and additional information have been requested for this complaint but have not become available.A review of the complaint history for the bhr head and bhr cup was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.Similar complaints have been identified.This will continue to be monitored.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.All the released devices involved met manufacturing specifications 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 and no further actions are required at this time.The available medical documents were reviewed.The clinical information provided, of the elevated metal ion levels, pain, stiffness, loss of mobility, and metallosis, may be consistent with a reaction to metal debris.However, the source and the root cause cannot be determined with the available documentation.It cannot be concluded that the reported clinical findings are associated with the implant failure.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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Manufacturer Narrative
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Section h3, h6: it was reported that a left revision surgery was performed due to severe pain, failed left hip resurfacing, stiffness, loss of mobility, and metallosis.As of today, the implanted devices, all of which were used in treatment have not been returned for evaluation.A review of the historical complaints data for the devices concerned was performed using batch numbers, part numbers and the reported failure modes to evaluate patterns of repeated failures or defects.Similar complaints have been identified for the head and the cup, and this failure will continue to be monitored.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.All released devices involved met manufacturing specifications upon release for distribution.The review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.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.No further actions are required at this time.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.The available medical documents were reviewed.The clinical information provided, of the elevated metal ion levels, pain, stiffness, loss of mobility, and metallosis, may be consistent with a reaction to metal debris.However, the source and the clinical root cause cannot be determined with the available documentation.It cannot be concluded that the reported clinical findings are associated with an implant failure.Impact to the patient beyond the reported pain, the revision surgery, and the recovery, cannot be determined; however, it is noted patient was doing well 4.5 weeks post revision.Based on the information provided, further investigation of the reported complaint cannot be carried out and remains inconclusive.A definitive root cause cannot be determined.Specific factors known to contribute to the alleged fault are excessive physical activity levels, unreasonable stress on replacement system, excessive patient weight, trauma to the joint replacement, loosening of components may increase production of wear particles and accelerate damage to the bone.Should the devices or additional information be received, the complaint will be reopened.Based on this investigation, the need for corrective and preventative actions is not indicated.
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Manufacturer Narrative
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H10.Additional information in a2, b6 and b7.H11.Corrected information in b5 and h6 (medical device problem code).
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Event Description
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It was reported that the patient underwent medically-indicated revision of the bhr left hip implants on (b)(6) 2019.The revision surgery was performed due to severe pain, failed left hip resurfacing, stiffness, loss of mobility, and metallosis.During the revision surgery, both metallic components were explanted and replaced with tha system.The patient outcome is unknown.
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