Model Number N/A |
Device Problem
Material Erosion (1214)
|
Patient Problems
Pain (1994); Reaction (2414)
|
Event Date 02/28/2019 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to location of device is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 01307.
|
|
Event Description
|
It was reported that a patient underwent hip revision approximately 18 years post implantation due to high elevated ion metals and multiple pseudo tumors.Attempts have been made and additional information on the reported event is unavailable at this time.
|
|
Manufacturer Narrative
|
Complaint sample was evaluated and the reported event was not confirmed.Review of the available records identified the following: right hip demonstrates a right total hip arthroplasty with cement fixation of the acetabular cup.No radiolucency along the acetabular cup.Rounded lucency along the greater trochanter could suggest osteolysis or postsurgical change.Heterotopic ossification along the lateral acetabulum.Review of the device history record(s) identified no deviations or anomalies during manufacturing.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
|