Section h10: (a1) patient identifier: (b)(6).(a2) age at the time of event: 71 years.(b2) added check for hospitalization - initial or prolonged.(d4) serial number: (b)(6), expiration date: 19-feb-2028, unique identifier (udi) #: (b)(4).Initial reporter occupation: physician.(g5) pma/510(k)number: k152217.(h3) the loosening reported was likely the result of an insufficient bond between the implant and the bone, which led to aseptic (non-infected) loosening of the tibial component and pain.However, this cannot be confirmed because the component was not available for evaluation.(h4) device manufacture date: 21-feb-2018 (h6) evaluation codes: 1924, 4002 section h11: *the following sections have corrected information: (e2) health professional?: yes.(g3) should of been checked health professional on initial report.*no information provided in the following section(s): b6, g8, d7, d11,g8, h7, h9.
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