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It was reported that, after primary left r3 tha surgery was performed on (b)(6) 2009, the patient experienced metallosis.This adverse event was treated with revision surgery on (b)(6) 2021.During the revision, dark metallic fluid was found in the hip.The metallic liner, femoral head and femoral head sleeve were explanted and replaced with a ceramic and poly articulation system.The patient was brought to the recovery room in stable condition.
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H10: internal complaint reference: (b)(4).H3, h6: it was reported that left hip revision surgery was performed.As of today, the implanted devices, all of which were used in treatment have not been returned for evaluation.Without definitive lot numbers a complete complaint history review cannot be performed for the hemi head.A review of the historical complaints data was performed 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.Other similar complaints have been identified for the part number and the reported failure mode, however, as the device is no longer sold, no action is to be taken.A review of the historical complaints data for the r3 liner 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 complaints were identified to involve this batch.Other similar complaints were identified for the part number and the reported failure mode.However, as the device is no longer sold, no action is to be taken.As no device batch numbers were provided for investigation for the hemi head, manufacturing record review, device labelling / ifu review could not be performed.If more information is received, this investigation will be reopened.In the absence of the actual devices, the production records were reviewed for the r3 liner involved in this incident.All released devices involved met manufacturing specifications upon release for distribution.Review of the product ifu for the r2 liner 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.Per the surgical technique, the acetabular component is to be impacted with 15-20 degrees of anteversion and 40-45 degrees of abduction.However, the operative report indicates that the acetabular component was implanted at 25-30 degrees of anteversion.It is unknown if this position of the acetabular component led to the reported pain and elevated metal ions along with the intraoperative findings of dark metallic fluid, metallosis, and trunnionosis.Although it was reported the patient¿s metal ion levels were elevated, neither the levels nor laboratory reports were provided for review.Without the supporting laboratory/pathology results, imaging, and/or the analysis of the explanted components, the root cause of the reported pain, elevated metal ion levels, and intraoperative findings cannot be confirmed.It cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant or implant failure.The patient impact beyond the pain, revision, and expected transient post-op convalescence period cannot be determined.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.Additionally, specific factors known to contribute to the alleged fault cannot be provided due to the insufficient information.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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