SMITH & NEPHEW, INC. COCR 12/14 FEM HEAD 32 + 4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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Model Number 71303204 |
Device Problem
Biocompatibility (2886)
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Patient Problems
Joint Dislocation (2374); Metal Related Pathology (4530)
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Event Date 03/23/2022 |
Event Type
Injury
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Manufacturer Narrative
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Internal complaint reference: case-(b)(4).Mastel, m., boisvert, a., moore, r., sutherland, f., & powell, j.(2022).Metallosis following hip arthroplasty: two case reports.Journal of medical case reports, 16(1), 1-9.Doi: https://doi.Org/10.1186/s13256-022-03336-4.
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Event Description
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"it was reported that on literature review ""metallosis following hip arthroplasty: two case reports"", one patient had a primary right hip tha surgery with a r3 acetabular shell, r3 poly liner, synergy stem and cocr femoral head.8 years after the primary surgery, the patient suffered from a dislocation and one year later, the patient sustained a second dislocation.The patient exhibited signs of metallosis and underwent a revision surgery to treat the adverse event.At 6 weeks follow-up, the patient was recovering well.
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Manufacturer Narrative
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The device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that no conclusions can be made from this publication as its limited to the information provided and further investigation is not possible.It was reported that at the 6 weeks follow-up, the patient was recovering well.No further clinical assessment is warranted at this time.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of complaint history of the previous 12 months revealed similar events for the listed device, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the instructions for use documents for total hip systems reveal in the postoperative section that patients should be warned against unassisted activity, particularly activities requiring excessive motion of the hip, as they may result in dislocation.Also, although rare, metal sensitivity reactions have been reported in patients following joint replacement, this has been identified in the adverse events in primary and revision surgery section.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.Possible causes could include but not limited to traumatic injury, patient anatomy, abnormal loading of limb, 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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