Catalog Number N |
Device Problems
Corroded (1131); Material Erosion (1214); Unstable (1667); Naturally Worn (2988)
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Patient Problems
Ossification (1428); Erosion (1750); Failure of Implant (1924); Pain (1994); Scar Tissue (2060); Osteolysis (2377); Osteopenia/ Osteoporosis (2651); Joint Laxity (4526); Metal Related Pathology (4530); Insufficient Information (4580)
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Event Date 07/06/2021 |
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 product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: part # unknown / unknown head/ lot # unknown.Part # unknown / unknown shell/ lot # unknown.Multiple mdr reports were filed for this event, please see associated reports: (b)(4).
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Event Description
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It was reported that patient underwent initial left total hip arthroplasty approximately 16 years ago.Subsequently, the patient has reported mild unknown symptoms and elevated chromium levels.However, no revision procedure has been reported to date.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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Reported event was unable to be confirmed.Device history record (dhr) review was unable to be performed as the item and lot number of the device involved in the event is unknown.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: summarized by hcp findings: recent metal ion levels cobalt 2.1 (normal <4.0), chromium 2.1 (normal <0.6) the left hip only has minor symptoms at this time root cause could not 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.
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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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The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported that patient underwent a left hip revision surgery 15 years post implantation due to metal related pathology.Pain and instability was reported.Surgeon noted surgery was extensive due to muscle damage, osteolysis, bone loss/erosion, ho and scar tissue 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.Medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues recent ion levels were high but lowered after the revision, extensive scar tissue, bone loss, muscle detachment, instability, wear debris, tumor, osteolysis, and altr as reported.Pain increase with weight-bearing.Corrosion on the head and taper, ho around the greater trochanter.No further complications were noted.The additional information does not change the outcome of the previous investigation.
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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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