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Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Cancer (3262)
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Event Date 06/19/2019 |
Event Type
Injury
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Manufacturer Narrative
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Zimmer biomet complaint (b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.It is unknown at this time if the device will be returned for evaluation.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2019-00440, 0001032347-2019-00441, 0001032347-2019-00442.Concomitant medical products¿ tmj system left fossa component, small, cat# 24-6563, lot# 166460a; tmj system left standard mandibular component, cat# 24-6556, lot# 831890b; "2,4mm" system high torque (ht) cross-drive screw, cat# 91-2710, lot# unk; tmj system cross drive fossa screw, cat# 99-6577, lot# unk.Occupation ¿ patient.
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Event Description
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It was reported a patient underwent a revision to remove temporomandibular implants on the left side.The implant was removed due to squamous cell carcinoma in the oral cavity.Attempts have been made but no further information is available.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The complaint is non-verifiable.No product was returned; therefore, no functional tests or inspections could be performed.An x-ray was received, however, the x-ray showed a right mandible plate which spanned a gap between the patient's ramus and chin, and was fractured at the chin.Five follow up attempts were made for additional information regarding this implant's identity and scans relating to the left mandible and left fossa components in this complaint file.Tmj tracking confirmed that a left mandible (part# 24-6556, lot# 831890b), left fossa (part# 24-6563, lot# 166460a) and screws (part# 91-2710, 99-6577) were implanted on (b)(6) 2010.The provided x-ray was taken on (b)(6) 2019, prior to removal of the right mandible plate, and a nurse from the hospital confirmed that the right mandible was removed (b)(6) 2019.The x-ray was reviewed by the clinical research team, who concluded there was no evidence indicating that a tmj replacement surgery ever occurred on either side of the patient in the images.The most likely underlying cause cannot be determined.There are no additional indications of manufacturing defects.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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This follow-up report is being submitted to relay additional information.
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Search Alerts/Recalls
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