|
Device Problems
Corroded (1131); Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Cyst(s) (1800); Pain (1994); Metal Related Pathology (4530)
|
Event Date 05/03/2021 |
Event Type
Injury
|
Event Description
|
It was reported a patient underwent a left hip revision approximately eleven years post implantation due to abdominal pain, lateral hip tenderness and, laboratory confirmed, elevated metal ion levels.During the revision, periprosthetic osteolysis in the anterosuperior region, a small posterior pseudotumor, anterosuperior bone cyst, osteolytic defect and the head was cold welded.The head and taper were removed and replaced without complication.Attempts have been made and no further information is available.
|
|
Manufacturer Narrative
|
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-02878; 0001825034-2023-02879.D10: unknown magnum head; unknown neck taper.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 will be submitted.
|
|
Event Description
|
No additional event information to report at this time.
|
|
Manufacturer Narrative
|
(b)(4).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.Medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues.Failed left tha with periprosthetic osteolysis (anterosuperior region) and posterior pseudotumor (intracapsular ¿ posterior, quite small).Cobalt chromium levels elevated.The compliant is confirmed based on the evaluation of the provided medical records.A definitive root cause is unable to 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.
|
|
Search Alerts/Recalls
|
|
|