Model Number N/A |
Device Problems
Material Erosion (1214); Insufficient Information (3190)
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Patient Problems
Local Reaction (2035); Osteolysis (2377); Reaction (2414)
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Event Date 04/24/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: item # us257856, magnum trispike cup, lot # 264460; item #139252, m2a-magnum 42-50mm tpr insrt-6, lot # 920510; item #11-10421, mlry-hd lat por fmrl, lot # 303380.
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Event Description
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It was reported that a patient was revised approximately 10 years post implantation due to metallosis, elevated ion levels, altr and osteolysis.Operative notes indicated: upon entering the fascia lata, the patient did have some metallosis on his tissues; they were debrided; reactive tissue in the hip at this time as well.Attempts have been made, and no further information has been provided.
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Manufacturer Narrative
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Reported event was confirmed by review of medical records.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.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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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.Complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned product identified scuffing and scratching on the outer radius of the head.Gouges and dings are present on the rim.The taper insert was also returned.The exposed face is dinged and deformed.Light debris is present inside the taper.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.The additional information does not change the outcome of the previous investigation.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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Search Alerts/Recalls
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