Section h10: (a1) patient identifier: (b)(6).(a2) age at the time of event: 62 years.(b2) added check for hospitalization - initial or prolonged.(d4) serial number: (b)(6), expiration date: 09-feb-2028, unique identifier (udi) #: (b)(4).(g5) pma/510(k)number: k152217.(h3) the potential loosening reported was likely the result of an insufficient bond between the implant and the bone, which may have led to aseptic (non-infected) loosening of the tibial component.However, this cannot be confirmed because the component was not available for evaluation.(h4) device manufacture date: 12-feb-2018.Section h11: the following sections have corrected information: (e3) health professional?: should of stated yes.(g3) report source: should of been health professional on initial report.No information provided in the following section(s): b6, b7, d7, d11, g8, h7, h9.
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