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Model Number N/A |
Device Problems
Corroded (1131); Material Erosion (1214)
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Patient Problems
Necrosis (1971); Pain (1994); Loss of Range of Motion (2032); Synovitis (2094); Ambulation Difficulties (2544); Metal Related Pathology (4530)
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Event Date 04/24/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).The device will not be returned for analysis, due to location of device is unknown; however, an investigation of the reported event is in progress.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: 0002648920 - 2021 - 00131.
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Event Description
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It was reported that a patient underwent a right hip revision approximately 8 years ago.Subsequently, the patient was revised again approximately 2 years ago due to pain (which started 4 years ago), elevated metal ion levels, taper corrosion, and altr.The head, stem and liner were removed and replaced.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. no product was returned; visual and dimensional evaluations could not be performed.Medical records were not provided.Part and lot identification are necessary for review of device history records, neither were provided. zimmer biomet's head and stem were using in conjunction with a competitor's product.This is an incompatible combination and would be considered off-label usage.A definitive root cause cannot 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.The following sections were updated/corrected updated: a2, a3, a4, b5, b6, b7, e1, h2, h6.
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Event Description
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It was reported that a patient underwent a right hip revision.Subsequently, the patient was revised for the first time approximately 2.5 years later.The patient underwent another revision approximately 6 years later due to pain, elevated metal ions, difficulty ambulating, decrease rom, and altr.During the revision it was noted there was granulomatous tissue along with necrosis and corrosion.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.The following sections were updated/corrected.Updated: h2; h6.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: pain, elevated metal ions, mri: consistent with altr.Posterior pseudocapsule intact with no evidence of abductor tendon deficiency.Once incised noted moderate to severe synovial reaction with focal areas of granulomatous tissue along with necrotic type tissue.Acetabular and femoral components found well fixed and well aligned with fretting and corrosion noted.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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