Model Number N/A |
Device Problem
Insufficient Information (3190)
|
Patient Problems
Unspecified Infection (1930); Staphylococcus Aureus (2058)
|
Event Date 03/28/2017 |
Event Type
Injury
|
Manufacturer Narrative
|
The complaint number corresponding to this medwatch is (b)(4).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2017-02689, 0002648920-2017-00257, 0002648920-2017-00258, 0001822565-2017-02693 & 0001822565-2017-02694.
|
|
Event Description
|
It was reported that the patient's left hip was revised approximately three months post-implantation due to a deep infection, possible mrsa.All implants were removed and replaced with cement spacer molds.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional information.It was identified an internal software error produced and submitted an invalid device product code in the previous submissions related to this reporting.The device product code has been updated with no further changes.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 information available.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional information.Concomitant medical products: biolox⮠delta, ceramic femoral head, l, 㸠36/+3.5, taper 12/14 p/n 00877503603, l/n 2806905.Reported event was confirmed by review of provided office notes.Dhr was reviewed and no discrepancies were found.Sterilized devices manufactured or distributed by zimmer are sterilized in accordance with fda regulations and iso standards.Review of the complaint history determined that no further action is required.According to office visit notes the patient was diagnosed with an infection and inflammatory reaction due to the internal joint prosthesis and initial encounter.Methicillin-resistant staphylococcus aureus infection was identified at an unspecified site.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.
|
|
Search Alerts/Recalls
|