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Model Number N/A |
Device Problems
Unstable (1667); Noise, Audible (3273); Migration (4003)
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Patient Problems
Fall (1848); Pain (1994); Swelling (2091)
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Event Date 02/05/2018 |
Event Type
Injury
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Manufacturer Narrative
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Zimmer biomet complaint number (b)(4).Implant date: unknown month and day in 2010.Medical products: kne-vanguard-screws-unk; p/n: unk, l/n: unk, kne-vanguard-bearings-unk; p/n: unk, l/n: unk, kne-vanguard-femorals-unk; p/n: unk, l/n: unk, kne-vanguard-tibial trays-unk; p/n: unk, l/n: unk, bcm-other-unknown; p/n: unk, l/n: unk.Customer has not indicated that the product will not be returned to zimmer biomet for investigation.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: 0001822565 - 2019 - 04558 - 1, 0001825034 - 2019 - 05217, 0001825034 - 2019 - 05219, 0001825034 - 2019 - 05220.Product location is unknown.
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Event Description
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It was reported that the patient underwent a total knee arthroplasty and alleged pain, instability, clicking, swelling, and falling over twenty times.In addition, the patient alleges having had two procedures due to the screw becoming lost.Patient's medical records indicate that the patient underwent a revision procedure approximately eight years post-implantation.All products were removed and replaced with competitor products without complications.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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Complaint sample was evaluated via op-notes and the reported event was not confirmed.Primary surgery notes indicate no intra-operative complications.Revision surgery notes state that all components were replaced with competitor components.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.A summary of the investigation has been sent to the complainant.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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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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This follow-up report is being submitted to relay updated and additional information. concomitant medical products : series a pat thn 34 3 peg; p/n: 184786, l/n: 221300, vanguard cr tib brg 11x63/67; p/n: cp103404, l/n: 589310, vanguard cr por fem-rt 60; p/n: 183044, l/n: 930170, biomet cc cruciate tray 67mm; p/n: 141232, l/n: 948200, cobalt g-hv bone cement 40g; p/n: 402283, l/n: 007960.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 05242 - 1, 0001825034 - 2019 - 05217 - 1, 0001825034 - 2019 - 05219 - 1.
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Search Alerts/Recalls
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