An event regarding poly wear involving a securfit shell was reported.A clinical review confirmed the event.Device evaluation and results: a visual, dimensional, functional and material analysis inspection was not performed as the device was not returned for evaluation.Medical records received and evaluation: a review of the provided medical records and x-rays by a clinical consultant indicated: "the description of the acetabular component as "more vertical than normal" would suggest an inherently unstable hip that, after some poly wear, dislocated.It was noted on (b)(6) 2001 (four months status-post primary total hip) that the hip was popping in and out of place.The first revision done, in which a constrained liner was not available in the operating room, resulted in persistent instability causing the subsequent revision to a constrained liner two months later.During this surgery inherent instability of a 10° constrained liner further suggests the malposition of the acetabular shell.There is no evidence that factors of faulty prosthetic design, manufacturing, or materials were responsible for this clinical situation." device history review: all devices in the reported lot were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there has been one other event for the lot referenced, however, it is for the same patient.A medical review confirmed that the wear of the liner is a result of the shell positioning as noted "more vertical than normal" and "during this surgery inherent instability of a 10° constrained liner further suggests the malposition of the acetabular shell".No further investigation is required at this time.If additional relevant information becomes available, this investigation will be reopened.Not returned.
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