|
Model Number N/A |
Device Problem
Loosening of Implant Not Related to Bone-Ingrowth (4002)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/05/2021 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).Concomitant medical products: 00625006525- bone scr 6.5x25 self-tap- 64945776.00625006520- bone scr 6.5x20 self-tap- j6937390 00625006525- bone scr 6.5x25 self-tap- j7007857.110010264- g7 osseoti multihole 52mm e- 65028825.010000983-g7 freedom const e1 lnr 36mm e-7006050.Multiple mdr reports were filed for this event, please see associated reports: 0002648920 -2021 -00421, 0001822565 -2021 -03374, 0001822565 -2021 -03375.Customer has indicated that the product will not be returned to zimmer biomet for investigation, product requested but not returned by hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
|
|
Event Description
|
It was reported patient underwent a left hip revision two days post-implantation due to loosening.During the procedure the cup, liner, head, and screws were all replaced.Attempts to obtain additional information have been made; however, no more is available at this time.
|
|
Event Description
|
No additional information on the reported event.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records 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.
|
|
Search Alerts/Recalls
|
|
|