Product inquiry stated the reported long nail kit r1.5, ti, left gamma3® ø11x340mm x 125° to be the primary product.The other implants reported were considered as concomitant products as they did not contribute to the event reported.Review of the device history records revealed no discrepancies.The long nail kit was documented as faultless prior to distribution.No material, design or manufacturing related issues were found.A physical examination of the items could not be carried out as the devices were not returned to stryker (b)(4) (hospital policy).However, referring to the event description no product deficiency was subject of the event reported.In this case the cause for the implant removal was based on a fall of the patient.After approximately 4 weeks of implantation the patient fell and damaged her hip.The long nail kit was removed and replaced by a total hip.¿no hardware was broke.However damage was done to patient's hip as a result of the fall requiring another surgery.¿ the use of a total hip arthroplasty as revision implant leads furthermore to the assumption of a reduced bone quality.General aspects: implant removal may be necessary although no product deficiency is given.Possible reasons could be (but not limited to) non-union, cut-out, motor loss (potentially resulting from a fall) or multi-fractural-situation.Such harms do not primly depend on the implant.It is mostly caused by the kind of fracture, patient's general condition etc.With given information it can be concluded that the revision had to be carried out due a damaged hip.The reported information did not allege any deficiency in the identity, quality, reliability, safety, effectiveness or performance of the device.From technical point of view a further statement was not possible.With available information the cause of the event was most likely based on the patient¿s condition (fall).A deficiency of the product in question could not be verified.In case the products and / or relevant clinical information should become available, we reserve the right to update the investigation and change the root cause.Review of complaint history, capa databases and risk analysis did not identify any conspicuity.The review of the risk assessment for the failure mode indicated the issue was addressed adequately.There are no actions in place related to the reported event for the subject product.No non-conformity was identified.
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