Model Number N/A |
Device Problems
Device Dislodged or Dislocated (2923); Migration (4003)
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Patient Problem
Pain (1994)
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Event Type
Injury
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Manufacturer Narrative
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Zimmer biomet complaint #: (b)(4).Concomitant medical products: marahar pm-tmj & model catalog #: tmjpm-2685 lot #: 949090a foreign: (b)(6).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated report: 0001032347-2022-00167.
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Event Description
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It was reported that patient had original surgery to implant custom tmj prostheses approximately two years ago.Subsequently, all of the screws have pulled out and have radiolucencies around them.The surgeon stated that this suggests a systemic bone healing problem.The patient will need a revision, but the surgeon is having her worked up for a bone physiology disorder first as this could be part of her mctd or something different.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.2019 pre-op panorex, 2019 post-op panorex, april 2022 panorex and ct images were provided and reviewed by a health care professional.Review of the available images identified the following: pre-op imaging demonstrated suspected bilateral tmj arthrosis.2019 post-op imaging demonstrates anatomic alignment of bilateral custom tmj arthroplasties without abnormality.April 2022 imaging demonstrates loosening of the bilateral tmj arthroplasties with lucencies along the bilateral screws and slight retraction of the mandibular implants from the osseous margins.There is no osseous or hardware fracture.Patient anatomy appears unremarkable and unchanged, apart from bone quality appears mildly osteopenic.Part and lot identification are necessary for review of device history records, neither were provided for the screws.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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Search Alerts/Recalls
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