Catalog Number 650-1057 |
Device Problem
Scratched Material (3020)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/10/2023 |
Event Type
malfunction
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Event Description
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It was reported that when impacting a femoral head onto the stem, it was observed that the head was damaged due to being scratched.Another femoral head was opened, impacted onto the stem and it also was damaged.It was believed that the head impactor was damaged and left scratches.This event is related to a malfunction that could potentially lead to serious injury.Due diligence is in progress for this complaint; to date no additional information or product has been received.
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Manufacturer Narrative
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(b)(4).D10.Item#:650-1057 ;lot#: 3156908;item name: cer bioloxd option hd 36mm; item#:30103607 ;lot#: 65967765;item name: g7 vit e neutral lnr 36mm g; item#:650-1066 ;lot#: 3115067;item name: cer opt type 1 tpr sleve 0mm; item#:650-1057 ;lot#:3158159 ;item name: cer bioloxd option hd 36mm; item#:unknown impactor ;lot#:unknown ;item name: unknown impactor ; multiple mdr reports were filed for this event, please see associated reports: 3002806535 - 2023 - 00412.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d1, g3, g6, h1, h2, h6, h11.The analysis of information provided by a third party does not alter the findings of the previously reported investigation.If any further information is found which would change or alter any conclusions or information, a supplemental report 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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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Visual examination of the returned products confirmed both heads have marks to the outside diameter.Both heads exhibit metal transfer within their tapers indicating that they have been impacted during surgery.One head also has metal transfer on the lip of the device likely from the removal tool when it was removed to be replaced during surgery.A review of the device manufacturing records confirmed no abnormalities or deviations.Devices are used for treatment.Medical records were not provided.With the available information, a definitive root cause could not be determined however the surgeon states in the complaint that the head impactor was damaged and left the scratches.If any further information is found which would change or alter any conclusions or information, a supplemental report 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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Search Alerts/Recalls
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