Model Number N/A |
Device Problem
Insufficient Information (3190)
|
Patient Problem
Ossification (1428)
|
Event Date 04/04/2017 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).Concomitant medical devices: femoral head, part/lot unknown; acetabular cup, part/lot unknown; femoral stem, part 650-1124bmrsa, lot unknown.Report source: foreign.The event occurred in (b)(6).It has not been indicated the patient has had a device revision.The reporting states the ossification was removed.The devices are assumed yet implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device remains implanted.
|
|
Event Description
|
It was reported the patient had an adverse event of heterotopic ossification of the right hip.It was stated the adverse event was not device related, but possibly related to the procedure.The ossification was removed and the issue was considered resolved.No further information is available at this time.
|
|
Manufacturer Narrative
|
(b)(4).The reported event could not be confirmed based on limited information received.No products were returned; therefore, the visual and dimensional inspections were not performed.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.The compatibility check and complaint history search were not performed.A definitive root cause cannot be determined with the information provided.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.
|
|
Manufacturer Narrative
|
The following report is submitted to relay the corrections received: (b)(6).The corrections contained within this report have no effect on previous investigation conclusion.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
|