|
Model Number N/A |
Device Problems
Unstable (1667); Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)
|
Patient Problems
Pain (1994); Limited Mobility Of The Implanted Joint (2671)
|
Event Date 09/09/2019 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).Concomitant medical products: biomet cc cruciate tray; p/n: 141231, l/n: j3884994.E1 vngd crl tib brg; p/n: ep-183522, l/n: 141070.Vanguard cr ilok fem-lt; p/n: 183028, l/n: j6077425.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 - 2019 - 04386, 0001825034 - 2019 - 04445.
|
|
Event Description
|
It was reported the patient had a revision procedure 2 years post-implantation due to due to pain, difficulty ambulating, having to use a walker, instability, and subsidence.Subsequently, loosening of the components lead to valgus alignment.The polyethylene bearing, femoral component and tibial tray was removed and replaced.No additional patient consequences were reported.
|
|
Event Description
|
Upon receipt of additional information it has been determined that this device did not cause or contribute to the reported event.The initial report was submitted in error and should be voided.
|
|
Manufacturer Narrative
|
Upon receipt of additional information it has been determined that this device did not cause or contribute to the reported event.The initial report was submitted in error and should be voided.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
|
|
|