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Model Number N/A |
Device Problems
Degraded (1153); Material Erosion (1214)
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Patient Problems
Failure of Implant (1924); Pain (1994); Local Reaction (2035); Metal Related Pathology (4530)
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Event Date 05/22/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: us157852 m2a-magnum pf cup 739950, 13-103206 taperloc stem 882420, 139254 m2a-magnum tpr insrt 419680.Customer has indicated that the product will not be returned to zimmer biomet for investigation.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: 0001825034-2022-00995.
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Event Description
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It was reported a patient underwent a right total hip arthroplasty performed.The patient was revised just over ten years post implant due to pain and elevated cobalt and chromium levels.It was discovered during the revision, pseudocapsules was noted, there was no obvious damage to tissues or surrounding structures; however, black discoloration associated with wear was noted.The femoral head was replaced with a dual mobility construct without complication.Attempts have been made and no further information has been provided.
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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 h6: component code: mechanical (g04) - head 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: developed pain, cobalt and chromium levels were elevated, mri negative for pseudotumor or tissue destruction.Gradient black discoloration of the tissues adjacent to the joint, pseudocapsule incised.Trunnion in good condition, stem stable, no tissue destruction, no pseudotumor, no osteolysis.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 available at the time of this report.
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Search Alerts/Recalls
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