Model Number N/A |
Device Problems
Malposition of Device (2616); Migration (4003)
|
Patient Problems
Failure of Implant (1924); Pain (1994); Swelling/ Edema (4577)
|
Event Date 08/05/2022 |
Event Type
Injury
|
Event Description
|
It was reported that upon review of the patient's scans, it was discovered that the condyle is in the ear canal due to incorrect placement of the fossa component, the mandible screws are not bicortical and the lower screw on the mandible looks loose.Patient was experiencing pain and swelling.Attempts have been made and no further information has been provided.
|
|
Manufacturer Narrative
|
Zimmer biomet complaint #: (b)(4).Concomitant medical products: medical devices: zimmer biomet mandible catalog #: ni; lot #:ni.Zimmer biomet fossa catalog #: ni; lot #:ni.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 reports: 0001032347-2022-00177 and 0001032347-2022-00178.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional information.
|
|
Event Description
|
It was reported that the implant was removed.Both the fossa and condyle elements were too near and pressing on the ear canal.The condyle element was articulating with the posterior part of the fossa and not the middle part as would be recommended.The implant was removed intact.
|
|
Event Description
|
This follow-up report is being submitted to relay additional information.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional information.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional information.D6a - (b)(6) 2014.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.Lot identification is necessary for review of device history records, lot identification was not provided for the mandible and fossa components.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.
|
|
Event Description
|
No further event information available at the time of this report.
|
|
Search Alerts/Recalls
|