Model Number N/A |
Device Problems
Difficult to Remove (1528); Use of Device Problem (1670)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/27/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Concomitant medical products: item #00500105328 liner for use with o.D.Shells lot #64135452.Item #unknown, unknown stem, lot #unknown.Item #unknown, unknown head, lot #unknown.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2019-02590.
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Event Description
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It was reported that the inner ring on the bipolar shell was lodged into one side of the opening, which prevented it from locking onto the liner.The surgeon was unable to dislodge the locking ring and stated that it was not usable.When attempting to implant the shell, part of the inside locking ring scratched the liner.Another liner was used for the procedure.There was no injury or harm done to the patient due to this event.Additional information was requested however, none was available.
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Manufacturer Narrative
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Upon reassessment of the reported event, it was determined an mdr should not have been filed under the current mfr number.This event will be reported on 0002648920 - 2019 - 00831.
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Event Description
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Upon reassessment of the reported event, it was determined an mdr should not have been filed under the current mfr number.This event will be reported on 0002648920 - 2019 - 00831.
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Search Alerts/Recalls
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