|
Model Number N/A |
Device Problem
Naturally Worn (2988)
|
Patient Problems
Failure of Implant (1924); Pain (1994); Synovitis (2094)
|
Event Date 09/12/2023 |
Event Type
Injury
|
Event Description
|
It was reported that approximately 12 years post implantation, the patient was revised of the poly articular surface due to wear, synovitis, and pain.No additional information available.
|
|
Manufacturer Narrative
|
(b)(4).G2: (b)(6) customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was discarded by the facility.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Additional associated products: 183026 vanguard cr ilok fem-lt 62.5 lot# 837560; 141252 polished finned tib tray 67mm lot# 2011020446; 66022663 lot 72134262 palacos bone cement (heraeus).
|
|
Manufacturer Narrative
|
this follow-up report is being submitted to relay additional information.Visual examination of the provided pictures identified sign of use with delamination and extreme wear.Review of the device history record(s) identified no deviations or anomalies during manufacturing.The reported products were reviewed for compatibility with no issues noted.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified no intra operative complication during the initial surgery.Complaint was confirmed based on the provided picture.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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 further event information available at the time of this report.
|
|
Search Alerts/Recalls
|
|
|