Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
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48mm pinnacle sector gription (121732048) shell would not release from pinnacle cup inserter (221750041).The shell and inserter were damaged while separating them.A new shell was opened for implantation.The damaged shell and inserter have discarded.No lot numbers or serial number available.There was no surgical delay and no patient consequence.A replacement shell and cup inserter are required.Please send replacements to: (b)(6).Bill to: ¿0010202111¿ ship to: ¿0010202612¿ no charge po to follow.Customer reference/po/service --> to follow, was surgery delayed due to the reported event? --> no, was procedure successfully completed? --> yes, were fragments generated? --> no, if yes, were they removed easily without additional intervention? --> unknown, patient status/ outcome / consequences --> no, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: --> unknown, is the patient part of a clinical study --> unknown, (b)(4).Device property of -->none, device in possession of -->none, (b)(4).Device property of -->none, device in possession of -->none.By checking this box i certify that all information that are known/available has been disclosed.If any new information will be made available, the additional information will be submitted through cst.--> true.
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