Catalog Number 00725504828 |
Device Problems
Unstable (1667); Device Dislodged or Dislocated (2923); No Apparent Adverse Event (3189); Migration (4003)
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Patient Problems
Pain (1994); Joint Dislocation (2374)
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Event Date 04/26/2019 |
Event Type
Injury
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Manufacturer Narrative
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Investigation in progress.
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Event Description
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Legal counsel for patient reported that patient underwent initial left hip procedure on (b)(6) 2011.Further the legal counsel reports that the patient underwent a reduction procedure due to pain and dislocation on (b)(6) 2018.
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Event Description
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Legal counsel for patient reported that patient underwent initial left hip procedure on (b)(6) 2011.Further the legal counsel reports that the patient underwent a reduction procedure due to pain and dislocation on (b)(6) 2018.This report is based on allegations set forth in plaintiff¿s complaint and the allegations contained therein are unverified.
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Manufacturer Narrative
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No product was returned so visual and dimensional evaluations could not be performed.Device history records were reviewed for the part number 00725504828 and lot number 60884455 and no deviations or anomalies were found.The product was likely conforming when it left zimmer biomet control.Complaint history search for the combination of below part and lot numbers performed.No additional complaints found for the same part and lot number: part number 00725504828 and lot number 60884455 recall holds search could not be performed as device numbers have not been provided.Surgical notes or x-rays were not provided.Requests were conducted through dl for more information regarding this event.Due to the litigation process, little detail is available to aid in this investigation at this time.A definitive root cause cannot be determined with the information provided.No corrective actions, preventive actions, or field actions resulted after investigation of this event.
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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 update/corrected updated: a2, a3, b3, b4, b5, d7, g4, g7, h2, h3, h6 medical records were provided and reviewed by a healthcare professional.Review found that the patient had spontaneous hyper flexion reduced in the er 7 year post implantation.X-rays revealed a stable hip with well seated and well aligned prosthesis.Patient was revised approximately 7 months later due to unstable left hip replacement with multiple dislocations.The acetabular cup had slipped from its initial position and there was a dent in the polyethylene.Femoral stem was well seated and not loose.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause was unable to 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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It was further reported that approximately 7 months post reduction, the patient underwent a revision of the l tha due to instability and multiple dislocations.Intraoperatively, the cup was found to have migrated from its initial position and there was a dent in the polyethylene.No further information is available for this event.
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Search Alerts/Recalls
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