SMITH & NEPHEW ORTHOPAEDICS LTD RESURFACING FEMORAL HEAD 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
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Model Number 74121150 |
Device Problem
Biocompatibility (2886)
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Patient Problems
Cyst(s) (1800); Failure of Implant (1924); Arthralgia (2355); Metal Related Pathology (4530)
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Event Date 08/02/2021 |
Event Type
Injury
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Manufacturer Narrative
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Internal complaint reference: (b)(4).
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Event Description
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*us legal* it was reported that, after a bhr resurfacing construct had been implanted on the patient¿s left hip on (b)(6) 2010, the patient experienced extensive metallosis, joint pain, large anterior fluid cyst and damage to antero-superior region of the acetabular implant.A revision surgery was performed on (b)(6) 2021 to treat this adverse event.During this procedure, an extensive metallosis staining of the soft tissue around the hip was visualized and carefully debrided.The bhr resurfacing head was removed upon performing a femoral neck cut.The acetabular cup presented an anterior superior wear and a defect in the surface of the cup, making it necessary to revise this component as well.The hip was converted into a full thr system.The patient was transferred to the recovery room in stable condition.
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Event Description
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It was reported that, after a bhr resurfacing construct had been implanted on the patient¿s left hip on (b)(6) 2010, the patient experienced extensive metallosis, joint pain, large anterior fluid cyst and damage to antero-superior region of the acetabular implant.A revision surgery was performed on (b)(6) 2021 to treat this adverse event.During this procedure, an extensive metallosis staining of the soft tissue around the hip was visualized and carefully debrided.The bhr resurfacing head was removed upon performing a femoral neck cut.The hip was converted into a full thr system.The patient was transferred to the recovery room in stable condition.
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Manufacturer Narrative
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H3, h6: it was reported that a let hip revision surgery was performed.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 acetabular cup and femoral head was performed using batch numbers to evaluate patterns of repeated failures or defects over the lifetime of the product and 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 no other similar complaints were identified to involve this batch.Other similar complaints were identified for the part number and the reported failure mode.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 released devices involved met manufacturing specifications upon release for distribution.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.A review of historic escalation actions related to the products and similar complaint events was performed.Following the review, prior applicable escalation actions were identified and confirmed to reduce associated risks as far as possible.No further escalation actions required.The available medical documents were reviewed.Based on the reported symptoms it cannot be concluded that the events/clinical reactions (pain, extensive metallosis, fluid collection, and damage to the acetabular cup) were associated with a mal-performance of the implant.The patient impact cannot be determined at this time.Based on the available information we can confirm the reported complaint, however without further information our investigation remains inconclusive, and 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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Search Alerts/Recalls
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