Model Number N/A |
Device Problem
Device Dislodged or Dislocated (2923)
|
Patient Problems
Fall (1848); Joint Dislocation (2374)
|
Event Date 10/01/2022 |
Event Type
Injury
|
Event Description
|
It was reported the patient underwent a hip revision approximately 3 years post implantation due to a fall causing a dislocation.
|
|
Manufacturer Narrative
|
(b)(4).Concomitant medical products: cat#010000850 lot#6489079 liner, cat#51-113140 lot#6537103 stem, cat#110010266 lot#6463340 shell.Foreign source: australia.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2022 - 02421.
|
|
Event Description
|
No further event information available at the time of this report.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional information.H6: proposed component code: mechanical (g04) - head.Reported event was unable to be confirmed due to limited information received from the customer.Radiographs provided were taken 3 months before the dislocation and were not assessed.Device history record (dhr) was reviewed and no discrepancies were found.It was reported the patient dislocated due to a fall.As the reason for the fall is unknown, 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.
|
|
Manufacturer Narrative
|
Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number: (b)(4).
|
|
Event Description
|
Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number: (b)(4).
|
|
Search Alerts/Recalls
|