Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Wound Dehiscence (1154); Unspecified Infection (1930); Swelling (2091); Synovitis (2094); Limited Mobility Of The Implanted Joint (2671)
|
Event Date 06/01/2018 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).Concomitant medical devices: unk cup.Unk head.Unk stem.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-02688, 0001825034-2019-02690 and 0001825034-2019-02691.It is unknown if product will be returning to zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
|
|
Event Description
|
It was reported that the patient developed signs and symptoms of wound infection approximately 6 months post op.Patient had redness, swelling, difficulties ambulating, osteomyelitis, and sepsis.I&d was performed and components were revised.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional information.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 additional event information to report at this time.
|
|
Search Alerts/Recalls
|