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Model Number N/A |
Device Problems
Corroded (1131); Material Erosion (1214)
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Patient Problem
Pain (1994)
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Event Date 06/08/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: 00801803601, femoral head sterile product do not resterilize 12/14 taper, 62246369.00630505036, liner standard 3.5 mm offset 36 mm i.D.For use with 50/52/54 mm o.D.Shells, 62237309.00625006540, bone scr 6.5x40 self-tap, 6263468.00620205222, shell porous with cluster holes 52 mm, 62214397.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 02349.Customer has indicated that the product will not be returned to zimmer biomet for investigation, not returned by patient.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 the patient underwent a right hip revision approximately 7 years post implantation due to pain caused by elevated metal ions levels.Head and liner were revised.Attempts have been made and additional information on the reported event is unavailable at this time.
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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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Reported event was unable to be confirmed.Operative notes for the initial surgery were provided and reviewed by a healthcare professional; no intraoperative complications were noted.No operative notes were provided for the revision procedure.An x-ray was submitted with this complaint.As the image is not dated, and the complaint is for revision due to metal ions, submitting an x-ray image would not enhance the investigation for metal ions, as that would require a ct/mri image.Review of the device history record for the stem identified no deviations or anomalies during manufacturing related to the reported event.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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Upon reassessment of the reported event, this report should be voided as it was determined to be a duplicate of mfr number 0001822565 - 2019 - 04851.
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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: b5; g3; h2.Upon reassessment of the reported event, this report should be voided as it was determined to be a duplicate of mfr number 0001822565 - 2019 - 04851.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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Search Alerts/Recalls
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