Model Number N/A |
Device Problems
Metal Shedding Debris (1804); Naturally Worn (2988); Insufficient Information (3190)
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Patient Problems
Pain (1994); Tissue Damage (2104); Discomfort (2330); Reaction (2414); Limited Mobility Of The Implanted Joint (2671); No Information (3190)
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Event Date 12/08/2014 |
Event Type
Injury
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Manufacturer Narrative
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Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.This report is based on allegations set forth in plaintiff¿s complaint, and the allegations contained therein are unverified.
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Event Description
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Patient's legal counsel reported patient underwent right hip revision procedure approximately five years post-implantation due to unspecified allegations.This report is based on allegations set forth in plaintiff's complaint, and the allegations contained therein are unverified.
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Manufacturer Narrative
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(b)(4).This follow up report is being submitted to relay additional information.Concomitant products- part: us157844 name:m2a-magnum pf cup 44odx38id lot: 269730 part: 14-103200 name:micro taperloc std pc 5mm t1 lot: 847320.
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Event Description
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It was reported that a patient was revised approximately 5 years post-implantation due to pain, discomfort, and lack of mobility.Attempts have been made and no further information is available at this time.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.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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It was reported that a patient was revised approximately 5 years post-implantation due to pain, discomfort, lack of mobility, tissue and bone destruction, metal wear, and metal poisoning.Attempts have been made and no further information is available at this time.
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Manufacturer Narrative
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(b)(4).This follow-up report is being filed to relay additional information which was unknown at the time of the intial medwatch.
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Search Alerts/Recalls
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