Model Number N/A |
Device Problems
Positioning Failure (1158); Difficult to Insert (1316); Off-Label Use (1494)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Information (3190)
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Event Date 03/27/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).(b)(6).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.
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Event Description
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It was reported that the patient had an initial hip replacement on an unknown date.The patient was then revised for unknown reasons and the liner was replaced.During the procedure, the first liner did not fit into the shell.The surgery was finished with backup liner.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.Updated: b4, b5, d11, g4, h2.D11: 110010243 g7 osseoti 3 hole shell 6561847.010000998 g7 screw 6.5mm x 25mm 6489256.010000998 g7 screw 6.5mm x 25mm 6519889.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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Event Description
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No further event information available at the time of this report.
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Event Description
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Not reportable: upon investigation, it has been determined that the device was used in an off label manner.Event is no longer considered reportable, and initial report should be voided.
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Manufacturer Narrative
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(b)(4) this follow-up report is being submitted to relay additional/corrected information.Updated: b4, b5, g4, h2, h3, h6 reported event was confirmed by visual examination of returned device.Device history record (dhr) was reviewed and no discrepancies were found.The root cause of the reported issue is attributed to off label use of items ep-155232 and 110010243.One epoly 32mm rlc lnr +5 sz22 was returned and evaluated.Upon visual inspection there is a circular indentation and a scratch visible on the outside radius on the device.The scallops also have visible damage.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.Not reportable: upon investigation, it has been determined that the device was used in an off label manner.Event is no longer considered reportable, and initial report should be voided.
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Search Alerts/Recalls
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