Model Number N/A |
Device Problems
Migration or Expulsion of Device (1395); Migration (4003)
|
Patient Problems
Wound Dehiscence (1154); Pain (1994); Ulcer (2274)
|
Event Date 03/29/2021 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The product location is unknown.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 month post op with the orthosorb pin coming through the skin.Attempts have been made and no further information has been provided.
|
|
Event Description
|
No further event information available at the time of this report.
|
|
Manufacturer Narrative
|
(b)(4).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.
|
|
Manufacturer Narrative
|
(b)(4).This follow-up report is being submitted to relay additional information.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.
|
|
Event Description
|
No further event information available at the time of this report.
|
|
Manufacturer Narrative
|
(b)(4).This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of provided photographs and medical records.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown root cause was unable to be determined.Medical identified no contributing factors of the event.Pain was noted in the left toe with absorbable pin protruding out of wound; the pin was removed, cultures taken, and dressing applied.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
|
|
Search Alerts/Recalls
|