Model Number N/A |
Device Problems
Corroded (1131); Material Erosion (1214); Loosening of Implant Not Related to Bone-Ingrowth (4002)
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Patient Problems
Necrosis (1971); Pain (1994); Scar Tissue (2060); Osteolysis (2377); Ambulation Difficulties (2544); Metal Related Pathology (4530); Muscle/Tendon Damage (4532)
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Event Date 12/08/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Report source: foreign: country: (b)(6).Concomitant products: ref 00625006520 lot 61296269 screw; ref 00625006525 lot 61336958 screw ; ref 00625006525 lot 61319989 screw ; ref 00801803203 lot 61081380 versys head ; ref 00620005622 lot 61235876 trilogy shell ; ref 00632005632 lot 60710433 longevity liner.Customer has indicated that the product will not be returned to zimmer biomet for investigation.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: 0002648920 - 2021 - 00454, 0001822565 - 2021 - 03541.
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Event Description
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It was reported the patient underwent a left hip revision approximately 11 years post implantation due to pain and metal related pathology.During the revision, metallosis and pseudotumor were noted.The head, liner, and stem were replaced without complication.No additional information.
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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 due to the review of medical records.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: an initial left tha was performed.A revision occurred due to pain and metal related pathology.During the revision, a pseudotumor and metallosis was found within the joint, as well as loosening of the stem.Additionally, there was trunnionosis and osteolysis.A new zimmer head, stem and liner were placed without complication.Device history record (dhr) was reviewed and no discrepancies were found.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 is 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.Product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.H6: component code: mechanical (g04)-stem.Additional medical records were provided and reviewed by a health care professional.Review of the available records identified the following: additional medical records related to testing and ct scans confirmed loosening, elevated metal ions, and pseudotumor.The reported issue was confirmed based on the provided medical records.The additional information does not change the outcome of the previous investigation, the root cause remains unchanged.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 is available at the time of this report.
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Search Alerts/Recalls
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