ZIMMER BIOMET, INC. DURASUL¿¢ HOODED INSERT SIZE 32MM I.D. X 53MM O.D.; PROSTHESIS, HIP
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Model Number N/A |
Device Problems
Unstable (1667); Device Dislodged or Dislocated (2923); Naturally Worn (2988); Unintended Movement (3026)
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Patient Problems
Failure of Implant (1924); Joint Dislocation (2374); Osteolysis (2377); Unspecified Tissue Injury (4559)
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Event Date 10/25/2021 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).00801803201-femoral head sterile product do not resterilize 12/14 taper-unknown, 00771101600-femoral stem 12/14 neck taper plasma sprayed press-fit cementless size 16.25 standard offset-unknown, 636000053-hemispherical porous shell with sealed screw holes 53 mm-unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 -2022 -00854, 0001822565 -2022 -00855.The reported event was confirmed via medical records reviewed by a health care professional.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Lot identification is necessary for review of device history records; lot identification was not provided.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.Device location unknown.
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Event Description
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It was reported patient underwent a right hip revision approximately 6 years post implantation due to instability, dislocations, and elevated metal ions.During the revision there was metal debris noted along the femoral neck, head, and trunnion which is intact with only minor crepitus erosion.There was extensive soft tissue and abductor mechanism loss with metallosis.Polyethylene wear and impingement posterior, hip was found dislocated.Osteolysis of the greater trochanter was found.The head, shell, and acetabular liner were exchanged without complications.The stem remains implanted.Attempts have been made and additional information on the reported event is unavailable at this time.
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