Model Number N/A |
Device Problems
Mechanical Jam (2983); Difficult or Delayed Separation (4044)
|
Patient Problems
Host-Tissue Reaction (1297); Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 09/26/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).Concomitant medical products: catalog number:00771301200 lot number:61365959 brand name: femoral stem, catalog number:00620205222 lot number: 61471539 brand name: acetabular shell, catalog number:00631005032 lot number:61429785 brand name: acetabular liner, catalog number:00801803202 lot number:61484661 brand name: femoral head.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2019-02876.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.Device not returned for evaluation.
|
|
Event Description
|
It was reported that during a revision surgery, upon attempting to remove the neck from the stem, surgeon noted it was fused.Attempts have been made and additional information on the reported event is unavailable.
|
|
Event Description
|
No further event information available at the time of this report.
|
|
Manufacturer Narrative
|
Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: patient underwent initial left tha and no complications were noted.8 years post implantation , scans and lab results revealed small joint effusion,an elevated cobalt level of 4.9 and a high chromium level of 3.7 and trunnionosis for which patient was revised.During revision, fusion was noted of the modular trunnion and femoral stem.Trochanter osteotomy was performed without complications and cables were used to repair osteotomy.Reported event was confirmed by review of medical report provided.Device history record was reviewed and no discrepancies were found.Root cause was 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.
|
|
Event Description
|
No additional information.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified signs of being implanted with wear and foreign material.The devices were returned assembled to each other.Medical records were also reviewed and identified fusion noted of the modular trunnion and femoral stem.Review of the device history records identified no deviations or anomalies during manufacturing.No problem was found with the devices as they are designed to achieve stable, long term fixation.Since the modular neck and stem junction are designed for longevity, the well-connected neck is a desired aspect.This complaint was confirmed based on evaluation of the returned devices.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
|