Model Number N/A |
Device Problems
Migration or Expulsion of Device (1395); Patient-Device Incompatibility (2682)
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Patient Problems
Fever (1858); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Pain (1994); Swelling (2091); Dizziness (2194); Limited Mobility Of The Implanted Joint (2671)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Review of the device history records show that the lot was released with no recorded anomaly or deviation.The warnings in the package insert state this type of event can occur.The product remains implanted in the patient and therefore will not be returned for an evaluation.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.This is report 2 of 2 for the same event.Report 1 of 2 is reported on mfr #0001032347-2016-00310.
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Event Description
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A patient reported experiencing a lot of pain, facial swelling on the left side, chronic sinus infections of the left side, fevers, dizzy spells, issues with hearing on the left side, and her ear gets bright red sometimes which makes her (and her surgeon) think she is allergic to the implant (although it is a titanium mandible).The patient adds that she feels like the implant is dislocated, like "maybe a piece of the fossa broke" since her "bite changes frequently." additionally, she reported that her "range of motion is not correct by about 50 to 55 degrees;" and that she has "a feeling as if the poly component has 'popped out' of socket." the patient states she may have a biofilm infection and received 3 doses of antibiotics (levaquin, vibramycin, and cefdinir).She states her surgeon recommended taking the implant out but the patient answered him that she wanted to do more research first.The patient states the surgeon suspects that maybe she might also have an infection in the joint and would need to take a culture to confirm.
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Manufacturer Narrative
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Though no product was returned, a device evaluation was conducted.According to the evaluation, the product identity has been confirmed.The patient states that she has been diagnosed with a biofilm infection of her left joint.A biofilm infection is a chronic infection of a particular area.The complaint was confirmed as the patient has preexisting pain and a chronic biofilm infection of the left temporomandibular joint.The allegations of swelling, dizzy spells, issues with hearing, and fevers, can all be attributed to the biofilm infection the patient has.The antibiotics were used to combat the existing biofilm infection and not due to the implant.Chronic pain and range of motion can be attributed to the patients existing condition as the patient is unlikely to regain full range of motion, but will see improvements to both range of motion and pain based on the preexisting condition before surgery.There are no indications of manufacturing defects.This is report 2 of 2 for the same event.Report 1 of 2 is reported on mfr #0001032347-2016-00310-1.
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Search Alerts/Recalls
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