|
Model Number N/A |
Device Problems
Material Erosion (1214); Device Dislodged or Dislocated (2923)
|
Patient Problems
Pain (1994); Joint Dislocation (2374)
|
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).Multiple mdr's were reported for this event.Please also see associated events: 0002648920 - 2018 - 00135, 0001822565 - 2018 - 01248.Concomitant medical products: unknown part/lot: acetabular cup, femoral head, femoral stem item # 00801803205 femoral head 12/14 taper lot # 60619313.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned to manufacturer.
|
|
Event Description
|
It was reported the patient was revised to address pain, dislocation, and implant wear.Intraoperatively, implant corrosion and alvallike (aseptic, lymphocyte-dominated vasculitis-associated lesion) symptoms were identified.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional information.The following sections were updated: reported event was unable to be confirmed due to limited information received from the customer.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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
|
|
|