(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2022-02637, 0001822565-2022-02638, 0001822565-2022-02676, 0001822565-2022-02677, 0001822565-2022-02678.Concomitant medical products: item#: 00434903603, 36mm a +3mm offset poly liner; lot#: 62114032, item#: 00434903611, 36mm a glenosphere; lot#: 62234748, item#: 00834902502, tm rvs base plt 25mm post +2; lot#: 62274777, item#: unknown, unknown screw length 36; lot#: unknown, item#: unknown, unknown screw length 42; lot#: unknown, item#: unknown, unknown glenoid bone void filler- autograft (glenoid); lot#: unknown, item#: unknown, unknown simplex cement; lot#: unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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(b)(4).This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2022-02637-1, 0001822565-2022-02638-1, 0001822565-2022-02676-1, 0001822565-2022-02677-1, 0001822565-2022-02678-1.H6: component codes: mechanical (g04) - stem.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Medical records were provided and reviewed by a health care professional and a timeline was created.Review of the available records identified the following: 29-mar-2013; visit, improving; satisfied; anteroposterior & axillary images taken: no significant findings; an increase in pain due to suspected nerve pain; prescribed lyrica 75 mg.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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