Model Number N/A |
Device Problem
Insufficient Information (3190)
|
Patient Problems
Pain (1994); Sepsis (2067); No Information (3190)
|
Event Date 10/14/2017 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4) concomitant medical products: unknown stem, unknown femoral head.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-10099, and 0001825034-2018-10105.Reported event was unable to be confirmed as part number / lot number of device involved in the incident is unknown.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
|
It was reported that the patient underwent hip revision surgery due to unknown reasons.Attempts have been made and additional information on the reported event is unavailable.
|
|
Event Description
|
It was reported that the patient was revised approximately six years post initial surgery due to sepsis and worsening pain.No additional information available.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional information.Concomitant medical products : m2a magnum modular head (cat.No.157450, lot no.165290), m2a magnum taper adapter (cat.No.139256, lot no.298680), collared utegral porous stem (cat.No.170314, lot no.528690).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
|
This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of revision op notes.The revision op notes stated that patient underwent revision of right total hip arthroplasty due to pain and blood-borne infection consistent with mssa.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 further event information available at the time of this report.
|
|
Search Alerts/Recalls
|