It was reported that, after a revision tha had been performed on (b)(6) 2021, the patient experienced recurrent dislocations that led to the following interventions:.(i) a closed reduction of the hip on (b)(6) 2021; (ii) a physical evaluation and puncture of the hip under bv control for microbiological culture on (b)(6) 2021; (iii) closed reduction of the right hip on (b)(6) 2021; (iv) closed reduction of the right hip on (b)(6) 2021; and (v) revision surgery to exchange both the head and the r3 xlpe liner.The head is not from s+n.Patient condition did not improve afterwards.
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H6, h3: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, without the supporting lab/pathology results, imaging, and/or the analysis of the explanted components, the root cause of the reported recurring dislocations and closed reductions cannot be confirmed, and it cannot be concluded that the reported events were associated with a mal-performance of the implant.The patient impact beyond the closed reductions, revision, and expected transient post-op convalescence period cannot be determined.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.Possible causes could include but not limited to traumatic injury, patient anatomy or abnormal loading of limb.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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