SMITH & NEPHEW ORTHOPAEDICS LTD RESURFACING FEMORAL HEAD 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
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Catalog Number 74121150 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
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Patient Problems
Ossification (1428); Cyst(s) (1800); Pain (1994); Injury (2348); Osteolysis (2377); Metal Related Pathology (4530)
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Event Date 01/07/2020 |
Event Type
Injury
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Event Description
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It was reported that, after a left-side bhr construct had been implanted in a knee arthroplasty, the patient experienced unexplained pain, difficulty walking, pseudotumor and elevated chromium and cobalt levels.A medically-indicated revision surgery was performed to treat the adverse event.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 has been requested for this complaint but has not become available.A review of the complaint history for the bhr cup & 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.Device history record review confirmed that all released parts met specifications applicable 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 medical documents were reviewed.The revision operative report noted ¿pseudotumor, dark staining, dysvascular/avascular tissue, heterotopic bone and scar tissue.¿ it is also noted gram stains were all negative and tissue was negative for evidence of acute inflammation.Conclusion: the pseudotumor, dark staining, dysvascular/avascular tissue may be consistent with findings associated with metallosis; however, the root cause of the pseudotumor, dark staining, dysvascular/avascular tissue and metallosis cannot be confirmed and it cannot be concluded that the reported reactions were associated with a mal-performance of the implant.The root cause for the ¿heterotopic bone and scar tissue¿ cannot be concluded but some patients can be genetically predisposed they are known complications of joint surgeries and is related to the procedure and not the device.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 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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B3/b4/b5/b6 section corrected, section h6 updated.Event description corrected.
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Event Description
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It was reported that, after a left-side bhr surgery, the patient experienced unexplained pain, difficulty walking, pseudotumor and elevated chromium and cobalt levels.A medically-indicated revision surgery was performed to treat the adverse event.The patient outcome is unknown.
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