Model Number N/A |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
No Information (3190)
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Event Date 09/22/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Report source, foreign - event occurred in (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2019-00013 and 0001825034-2019-00015.The investigation is in process.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 a patient underwent an initial left hip replacement surgery on (b)(6) 2015.Subsequently, a revision procedure was performed on (b)(6) 2018 due to implant wear.This report is based on allegations set forth in patients notice and the allegations there in are unverified.
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Event Description
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It was reported that a patient underwent an initial left hip replacement surgery.Subsequently, a revision procedure was performed due to implant wear.This report is based on allegations set forth in patients notice and the allegations there in are unverified.
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Manufacturer Narrative
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(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Dhr review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to 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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Event Description
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It was reported that a patient underwent an initial left hip replacement surgery.Subsequently, a revision procedure was performed due to polyethylene implant wear.This report is based on allegations set forth in patients notice and the allegations there in are unverified.
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Manufacturer Narrative
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(b)(4).Concomitant medical products: medical product: mlry-hd 3hole rlc shl 60mm/l23 catalog #: 11-104160 lot #: 3200305, medical product: taperlc bmpc lat 9.0x137 12/14 catalog #: 650-0562bm lot #: 3312045, medical product: rloc-x e1 h/w +3mm 50/36mm 23 catalog #: ep-083650 lot #: 3549268.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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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Search Alerts/Recalls
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