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Model Number N/A |
Device Problems
Positioning Problem (3009); Insufficient Information (3190)
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Patient Problems
Host-Tissue Reaction (1297); Pain (1994); Osteolysis (2377); Osteopenia/ Osteoporosis (2651); No Information (3190)
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Event Date 01/25/2017 |
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.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (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 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.Concomitant medical products: item # unk, hip-mom-heads-unk, lot # unk, item # unk, hip-unknown-stems-unk, lot # unk.Multiple reports have been submitted for this event.Please see associated reports: 0001825034-2018-10142, 0001825034-2018-10143, 0001825034-2018-10144.
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Event Description
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It was reported that a patient was revised due to unknown reasons an unknown timeframe post implantation.Attempts have been made, and no further information has been provided.
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Event Description
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It was reported that a patient was revised approximately 12 years post implantation due to elevated ion levels, pain, corrosion, pseudotumor, malposition of cup, osteolysis and bone loss.Op notes indicated significant pain, elevated ion levels, and a pseudotumor.Other findings include: the cup is in an unacceptable angle, significant metal corrosion on the trunnion, upon removing the cup there was significant osteolysis and cavitary bone loss.Attempts have been made, and no further information has been provided.
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Manufacturer Narrative
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Concomitant medical products: item # 11-163667, m2a-magnum mod hd, lot # 042600, item # 15-105004, m2a-taper liner, lot # 809170, item # 11-103205, ntegral/xlat por, lot # 895150.An additional report has been submitted for this event: 0001825034-2018-11302.
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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 stating patient experienced significant pain, elevated blood metal ions, osteolysis and pseudotumor.Corrosion was also noted to be found during the surgery along with malpositioning of the cup component.Dhr was reviewed and no discrepancies 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 additional event information to report at this time.
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Manufacturer Narrative
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Complaint sample was returned and evaluated against the reported event.Upon visual inspection the shell shows scuffing and some dried cement.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 additional event information to report at this time.
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Search Alerts/Recalls
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