ZIMMER BIOMET, INC. LINER STANDARD 3.5 MM OFFSET 36 MM I.D. FOR USE WITH 58 MM O.D. SHELL; PROSTHESIS, HIP
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Model Number N/A |
Device Problems
Device Dislodged or Dislocated (2923); Unintended Movement (3026)
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Patient Problems
Tissue Damage (2104); Joint Dislocation (2374)
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Event Date 12/12/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: 00784804201, 61745801 ,modular neck r2 12/14 neck taper use with +0 heads only.00630505836, 62179849, liner standard 3.5 mm offset 36 mm i.D.For use with 58 mm o.D.Shell.00620205822, 62196455, shell porous with cluster holes 58 mm.Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the location of the device 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: 0002648920 - 2020 - 00337, 0001822565-2020-01977.
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Event Description
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It was reported patient underwent initial hip arthroplasty.Subsequently, the patient was revised approximately five years post implantation due to chronic dislocations and impingement.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.The following sections were: updated: b1, b4, b5, g4, g7, h1, h2, h3, h6, h10.Medical records were provided and reviewed by a health care professional.The patient underwent a revision procedure due to chronic dislocation and impingement.The patient experienced 4 dislocations due to flexion internal rotation type movement.A large trochanteric overgrowth impinged on the lateral aspect of the iliac wing.The head, neck, and liner were replaced and the limb length was extended.It was noted that an additional revision of the contralateral side was necessary due to metallosis.Reported event was confirmed by review of medical records provided.Device history record 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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