Model Number N/A |
Device Problem
Material Erosion (1214)
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Patient Problems
Scar Tissue (2060); Swelling (2091)
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Event Date 10/21/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical devices: 11-173665- m2a 38mm mod hd+9mm nk no skrt- 271090; 11-104212- mlry-hd lat por fmrl 12x165mm- 419500.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2021 - 00366, 0001825034 - 2021 - 00368.Customer has indicated that the product will not be returned to zimmer biomet for investigation, product location unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Product location unknown.
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Event Description
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It was reported patient underwent a revision surgery approximately 16 years post implantation due to elevated metal ion levels, pseudocyst, swelling, in-vivo corrosion and scar tissue.During the procedure the femoral head was dis-impacted.There was some black material on the trunnion.The trunnion was free of any mechanical defect that was visible.Some impingement noted anteriorly with the trials.Scar tissue was removed from within the anterior capsule as well as some of the areas of bony impingement, a small anterior portion of femur near the trochanter as well as some of the overhanging anterior bone of the acetabulum.The head component was removed and replaced with duel mobility.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 additional information on the reported event.
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Manufacturer Narrative
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Reported event was confirmed via medical records and radiographs reviewed by a health care professional.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The review of device history records identified no deviations or anomalies during manufacturing.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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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: d4; g3; h2; h4; h6.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 additional information on the reported event.
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Search Alerts/Recalls
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