Model Number N/A |
Device Problems
Fracture (1260); Unstable (1667)
|
Patient Problems
Fall (1848); Failure of Implant (1924); Pain (1994); Cancer (3262); Swelling/ Edema (4577)
|
Event Date 07/22/2022 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).Report source- united kingdom.Customer has indicated that the product will 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.
|
|
Event Description
|
It was reported that a patient fell and subsequently was revised due to hinge mechanism fracture and the plastic poly shield was worn down due to metal debris.Attempts to obtain additional information have been made; however, no more information is available at this time.
|
|
Manufacturer Narrative
|
This follow-up is being submitted to relay additional information.No product was returned, or pictures provided; therefore, visual and dimensional evaluations could not be performed.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: hinge post was fractured, exchanged femur, hinge mechanism and poly, there was a tumor with posterior bulge towards the vessels, knee reconstruction was complete, stable rom, with good tracking.Two drains were placed as well as wound vac for five to six days.Device history record (dhr) review was unable to be performed as the part and lot number of the device involved in the event is unknown.A definitive root cause cannot be determined.If any further information is which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
|
|
Event Description
|
It was reported that a patient was revised approximately one year and seven months post implantation due to pain, swelling, and instability.Noted during the revision implant fracture, metal debris, and inflammatory tissue.The femur, hinge mechanism and stem exchanged with unknown products without complications.
|
|
Manufacturer Narrative
|
This follow-up is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated report: 0001822565-2023-00096, 0001822565-2023-00097.D10 medical product: distal femoral xt component size b left, item#: 00585004201 lot#: 64892037.Articular surface with segmental hinge post size b 12 mm height.Item#: 00585002012, lot#: unknown.If any further information is which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
|
|
Event Description
|
No further event information available at the time of this report.
|
|
Manufacturer Narrative
|
This follow-up is being submitted to relay additional information.Visual examination of the provided pictures identified explanted femur, hinge, and articular surface.The hinge was broken in the picture.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: hinge post was fractured, exchanged femur, hinge mechanism and poly, there was a tumor with posterior bulge towards the vessels, knee reconstruction was complete, stable rom, with good tracking, lots of inflammatory tissue excised.Two drains were placed as well as wound vac for five to six days, patient claims instability occurred prior to falls.Hinge mechanism snapped and poly shield broken down due to metal debris.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.A definitive root cause cannot be determined.If any further information is which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
|
|
Event Description
|
No further event information available at the time of this report.
|
|
Manufacturer Narrative
|
This follow-up is being submitted to relay additional information.
|
|
Event Description
|
No further event information available at the time of this report.
|
|
Manufacturer Narrative
|
This follow-up is being submitted to relay additional information.Fracture analysis was performed on the hinge, and it was found that fatigue fractures occurred resulting in an overload failure.Medical records were sent and previously reviewed.This review remains unchanged.Device history record (dhr) was reviewed for deviations and/ or anomalies with no related deviations / anomalies identified.A definitive root cause cannot be determined.If any further information is received which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
|
|
Event Description
|
No further event information available at the time of this report.
|
|
Search Alerts/Recalls
|