Catalog Number 00784803101 |
Device Problems
Corroded (1131); Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)
|
Patient Problems
Failure of Implant (1924); Unspecified Infection (1930); Osteolysis (2377); Metal Related Pathology (4530)
|
Event Date 11/09/2022 |
Event Type
Injury
|
Event Description
|
It was reported that a patient underwent a revision approximately twelve years post implantation due to loosening, osteolysis, metal related pathology and an infection.During the procedure, loosing and osteolysis were noted, the stem and neck were removed and replaced.Attempts have been made and no further information is available.
|
|
Manufacturer Narrative
|
(b)(4).Multiple mdr reports were filed for this event.Associated report: 0001822565-2022-03372.Report source: australia.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, as supplemental medwatch will be submitted.
|
|
Event Description
|
No additional event information to report at this time.
|
|
Manufacturer Narrative
|
Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-00489, 0001822565-2023-00490.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.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause of the reported loosening, trunnionosis and osteolysis was unable to be determined as the necessary information to adequately investigate the reported event was not provided.No problem was found with the devices relating to the infection.Single-use, sterilized devices manufactured or distributed by zimmer biomet are sterilized in accordance with fda regulations and iso standards to a sterility assurance level of 1.0 x 10-6 or better.Therefore, it is unlikely that the specified device caused any patient infection.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.
|
|
Search Alerts/Recalls
|