Model Number N/A |
Device Problems
Loss of or Failure to Bond (1068); Loss of Osseointegration (2408)
|
Patient Problems
Pain (1994); Reaction (2414); Osteopenia/ Osteoporosis (2651)
|
Event Date 09/19/2017 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).Concomitant medical products: 00801803601 ¿ cocr head ¿ 63531216, 00771100520 ¿ m/l taper stem -62107673, 00630505036 ¿ xlpe liner ¿ 63357502.Customer has indicated that the product will not be returned to zimmer biomet for the investigation as the product location 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: 0002648920-2020-00172, 0001822565-2020-01282.
|
|
Event Description
|
It was reported that patient a left hip revision approximately 10 months post implantation due to severe pain.The patient was noted to have very poor bone quality.During the revision procedure, the acetabular shell was noted to be loose with inadequate osseointegration.One of the screws was noted to have pulled through the shell.Metallosis was debrided from the joint and the head, liner and shell components were removed and replaced.Attempts have been made and additional information on the reported event is unavailable at this time.
|
|
Event Description
|
No additional event information to report at this time.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: g4; h2; h3; h6.Reported event was confirmed by review of medical records noting patient was revised due to pain.During the procedure, metallosis was noted on the back border of the greater trochanter near the sutures.Clear yellow fluid with some metal debris was present.The acetabulum was found to be loose with only fibrous ingrowth and no bony ingrowth.One of the competitor¿s bone screws had passed through the cup.Dhr was reviewed and no discrepancies were found.The 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
|