Catalog Number 00549003624 |
Device Problems
Unstable (1667); Material Integrity Problem (2978)
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Patient Problem
Failure of Implant (1924)
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Event Date 09/07/2017 |
Event Type
Injury
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Manufacturer Narrative
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Device was not returned for evaluation.A review of the implant's manufacturing record indicates that it was manufactured to specification.It is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique.There is no indication that the augment block failed to meet specification or perform as expected.Tm femoral augment block, is the devices that was used as bone filling.Should additional information be obtained to further this investigation, this report shall be updated.Not returned by the hospital.
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Event Description
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It was reported that a patient underwent an initial knee procedure on (b)(6) 2015.The proximal portion of the offset stem extension was sheared off inside the a/p wedge implant that was in the patient.Subsequently, the patient was revised on (b)(6) 2017 due to failure of the implant.Implant failure no longer allowed the knee to be stable or functional on any level.Tm femoral augment block is the devices that was used as bone filling.This is the tmt design controlled part.
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Manufacturer Narrative
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Upon receiving additional information of the reported event, it was determined to be not reportable.The initial report should be voided.
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Event Description
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Upon receiving additional information of the reported event, it was determined to be not reportable.The initial report should be voided.
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Search Alerts/Recalls
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