Model Number N/A |
Device Problem
Loosening of Implant Not Related to Bone-Ingrowth (4002)
|
Patient Problem
Osteopenia/ Osteoporosis (2651)
|
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).Concomitant medical products: catalog #: unknown, humeral head, lot # unknown.Catalog #: unknown, humeral stem, lot # unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the hospital would not return it.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Requested but not returned by hospital.
|
|
Event Description
|
It was reported that the patient underwent a right shoulder procedure on an unknown date.Subsequently the patient has been indicated for a revision as the glenoid has come loose, there is also severe bone loss.No additional information available at this time.
|
|
Manufacturer Narrative
|
(b)(6).Reported event was unable to be confirmed due to limited information received from the customer.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 as the necessary information to adequately investigate the reported event was not provided.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
|
It was further reported that the surgery was never performed.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.
|
|
Search Alerts/Recalls
|