Model Number N/A |
Device Problem
Material Erosion (1214)
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Patient Problems
Cyst(s) (1800); Pain (1994); Local Reaction (2035); Tissue Damage (2104)
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Event Date 12/17/2014 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: 00784802200 ¿ m/l taper neck ¿ 60898630.00620205822 ¿ trabecular metal shell - 61120973.00625006525 ¿ bone screw ¿ 61238577.00625006530 ¿ bone screw ¿ 61197915.00630505840 ¿ xlpe liner ¿ 61250222.00771301500 ¿ m/l taper stem - 60850474.Customer has indicated that the product will not be returned to zimmer biomet for the investigation as the product location is unknown.The investigation is in process.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 - 2020 - 02286.0001822565 - 2020 - 02287.
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Event Description
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It was reported that patient underwent a left hip revision approximately 5 years post implantation due to malpositioning of the stem shell, pain and tissue damage.During the surgery, large fluid collection was noted anteriorly with a portion of the cyst cavity sent to pathology.Adverse response to metal debris and local inflammation with chronic irritation of the iliopsoas tendon was also noted.The stem was well fixed and required an extended trochanteric osteotomy to be removed.Attempts have been made and additional information on the reported event is unavailable at this time.
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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 patient underwent an initial left tha on (b)(6) 2009 with no intraoperative complications noted.The patient underwent a revision of the left tha on (b)(6) 2014 due to malpositioning, pain, and tissue damage.Xrays leading up to the revision indicated mild retroversion of the acetabular component and heterotopic bone around the left hip.During the revision, a large fluid collection was noted anteriorly.The stem was well fixed and required extended trochanteric osteotomy to remove.The acetabular component was noted to have significant retroversion; the modular stem was noted to have mild retroversion.Noted adverse tissue response to metal debris and local inflammation with chronic irritation of the iliopsoas tendon.Large amount of redundant cystic material presented itself in the joint.All components were explanted and new components were placed without complication.Dhr was reviewed and no discrepancies were found.The root cause is unable to be determined.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 03307.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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