|
Model Number N/A |
Device Problem
Material Erosion (1214)
|
Patient Problems
Pain (1994); Scar Tissue (2060); Synovitis (2094); Metal Related Pathology (4530); Unequal Limb Length (4534)
|
Event Date 09/25/2023 |
Event Type
Injury
|
Event Description
|
It was reported that approximately 9 years post implantation of a right total hip arthroplasty, the patient was revised for concern of metallosis development, elevated metal ion levels, and pain.The patient was noted to have a 7mm discrepancy between limbs.During the revision of the femoral head and limb lengthening procedure, scar tissue and synovial inflammation were also noted.There were no reported complications.No additional information was available.
|
|
Manufacturer Narrative
|
(b)(4).D10: cat# 157450 lot# 709400 m2a-magnum mod hd sz 50mm.Cat# 139259 lot# 105620 m2a magnum 42-50m tpr insrt +6.Cat# 192412 lot# 536270 echo por fmrl red nc 12x140mm.Product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2024-00861, 0001825034-2024-00862, 0001825034-2024-00863.
|
|
Search Alerts/Recalls
|
|
|