Model Number N/A |
Device Problems
Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993); Difficult or Delayed Separation (4044)
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Patient Problems
Host-Tissue Reaction (1297); Pain (1994); Osteolysis (2377)
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Event Date 05/15/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Unknown liner p/n unknown l/n unknown.It is unknown if product is being returned to zimmer biomet for investigation; however, an investigation has been initiated.Once the investigation has been completed, a follow- up mdr will be submitted.Multiple mdr reports were filed for this event.Please see associated reports: 0001822565-2017-02180, 0001822565-2017-02181, 0001822565-2017-02244.
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Event Description
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Legal counsel for patient reported patient was revised three years post-implantation due to discomfort, pain, and a tissue mass within the ileopsoas bursa suggestive of a metal-on-metal pseudotumor.Legal counsel further reported that during the procedure, there were signs of corrosion at the neck and stem junction, malfunction of the acetabular ring, and acetabular osteolysis.Attempts to obtain additional information have been made; however, no more is available at this time.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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This follow-up report is being submitted to relay additional information.Device history report review was unable to be performed as the lot number of the device involved in the event is unknown.Reported event was unable to be confirmed as part number / lot number of device involved in the incident was 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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Manufacturer Narrative
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This follow-up is being submitted to relay corrected information in explant date.Explant date - n/a, device was not explanted.This information does not alter previous investigation conclusions.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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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Concomitant products: part: 00-6310-050-32, xlpe 10deg poly liner505254x32, lot: unk; part: pha0-0268, wright medical technology profemur plasma zsz5 stem (competitor), lot: unk; part: 2600-0021, wright medical technology 32 mm metal head (competitor), lot: 1462754; part: pi-iacl224, wright medical technology ar/vv lng 1 cocr profemur neck (competitor), lot: unk.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.Reported event was confirmed by review of medical records noting pain, elevated metal ion levels, altr, particulate wear debris and corrosion.Osteolysis around the cup component was also noted with pseudotumor.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined.A summary of the investigation was sent to the complainant conveying proper surgical technique and use of the device.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 additional event information to report at this time.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Explant date is n/a, device was not explanted.Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2019-00787.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 experienced pain and elevated metal ion levels.The patient underwent a right hip revision approximately 3 years post implantation.During the procedure, physician noted pseudotumor, wear and the locking ring feature appearing to be bound up.The head, neck and liner components were removed and replaced.Attempts have been made and additional information on the reported event is unavailable at this time.
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Search Alerts/Recalls
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