|
Device Problem
Patient Device Interaction Problem (4001)
|
Patient Problems
Adhesion(s) (1695); Pain (1994); Scar Tissue (2060); Metal Related Pathology (4530)
|
Event Date 04/24/2020 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-02490.0001825034-2022-02491.0001825034-2022-02492.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, as supplemental medwatch will be submitted.
|
|
Event Description
|
It was reported that a patient underwent a left hip revision approximately twelve years post implantation due to pain.During the procedure, metal debris, corrosion to trunnion, scar tissue and adhesions were noted and the head, taper adapter was exchanged, and a bearing placed.Excessive blood loss was also noted at the end of the procedure, but no transfusion was required.It was reported that no further information is available.
|
|
Event Description
|
There is no update to the original complaint description provided.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional information.No product was returned; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.Device is used for treatment.Insufficient information provided.Complaint history review cannot be performed without product identification.Medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues pain, metal debris debrided in posterior external rotator region, mild corrosion on the trunnion, scar tissue from previous surgery.No other complications.A definitive root cause cannot be determined.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.
|
|
Search Alerts/Recalls
|
|
|