SMITH & NEPHEW, INC. R3 3 HOLE ACET SHELL 52MM; PROSTHESIS,HIP,SEMICONSTRAINED,METALCERAMICCERAMICMETAL,CEMENTEDORUNCEMENTED
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Model Number 71335552 |
Device Problems
Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hyperplasia (1906); Metal Related Pathology (4530)
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Event Date 08/16/2021 |
Event Type
Injury
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Manufacturer Narrative
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Internal complaint reference: case-2022-00103691-1.
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Event Description
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It was reported that, after right r3-tha was performed on (b)(6) 2010 due to right severe osteoarthritis, the patient experienced degenerative changes and mild synovial hyperplasia.This adverse event was treated with a revisions surgery on (b)(6) 2021.Patient's current health status is unknown.
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Manufacturer Narrative
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H3, h6: the device was not returned for evaluation.The pictures provided were reviewed and could not confirm the metallosis.The clinical/medical investigation concluded that, with the information provided the clinical root cause of the reported metallosis cannot confirmed.However, it is unknown if the retroverted acetabular component led to accelerated wear and the reported metallosis.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the instructions for use documents for hip systems provides complete guidelines of indications, contraindications, warnings and precautions and possible adverse effects that may occur preoperative, during surgery or post operative.It is unknown if the retroverted acetabular component led to accelerated wear and the reported metallosis.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include damaged product, implant corrosion or wear.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
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Event Description
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It was reported that, after right r3-tha was performed on (b)(6) 2010 due to right severe osteoarthritis, the patient experienced degenerative changes and mild synovial hyperplasia.When the acetabular component was retroverted, metallosis was confirmed.This adverse event was treated with a revisions surgery on (b)(6) 2021.Patient's current health status is unknown.
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Search Alerts/Recalls
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