Catalog Number 010000983 |
Device Problem
Device Dislodged or Dislocated (2923)
|
Patient Problem
Joint Dislocation (2374)
|
Event Date 01/15/2024 |
Event Type
Injury
|
Event Description
|
It was reported a patient underwent a right hip revision approximately three years post implantation due to a dislocation after a fall.It was reported that no further information is available.
|
|
Manufacturer Narrative
|
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2024-00383.Cat #: 802403604 / constrained head 12/14 taper 36 mm diameter +3 mm neck length for use with freedom constrained liners / lot #: 3037243.G2: australia.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
|
|
Manufacturer Narrative
|
(b)(4).This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The complaint was unable to be confirmed.Dhr was reviewed and no discrepancies related to the reported event were found.A definitive root cause cannot 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 additional event information to report at this time.
|
|
Search Alerts/Recalls
|