SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 52MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
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Catalog Number 74120152 |
Device Problems
Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273)
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Patient Problems
Inflammation (1932); Pain (1994); Toxicity (2333); Injury (2348)
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Event Date 02/27/2018 |
Event Type
Injury
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Event Description
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It was reported that left hip revision surgery was performed due to elevated metal ion levels, metallosis, fluid collection on mri, loss of hip function, pain, instability, inflammation and squeaking.
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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 has been requested for this complaint but has not become available.A review of the complaint history for the cup and head was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified for the head.Similar complaints were identified for the cup and 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.Review of manufacturing records did not reveal any waivers, concessions, manufacturing or material abnormalities that could have contributed to this issue.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 medical records were reviewed.Although the metal ion levels were reported to be elevated, neither the values nor the lab reports were provided.The root cause for the scar tissue cannot be concluded but some patients can be genetically predisposed, it is a known complication of joint surgeries and is related to the procedure and not the device.The reported pain may be associated with the intraoperative findings of fluid distention; however without the supporting lab/pathology results, imaging, and/or the analysis of the explanted components, the root cause of the reported pain cannot be confirmed, and it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.The patient impact beyond the pain, revision, and expected transient post-op convalescence period cannot be determined.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 re-opened.No preventative or corrective action has been initiated as a result of this investigation.
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Event Description
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*us legal* it was reported that after a left bhr construct was implanted on (b)(6) 2011, plaintiff experienced elevated metal ion levels, metallosis, fluid collection on mri, loss of hip function, pain, instability, inflammation, and squeaking.A revision surgery was performed on (b)(6) 2018 to treat these adverse events.During surgery a distention of the capsule due to fluid was found.6 weeks after revision surgery patient was reported to be stable and under normal recovering process.
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Search Alerts/Recalls
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