PROFEMUR® MODULAR FEMORAL NECK
Received Jun 1, 2023 · Event occurred Apr 14, 2023
Report 3010536692-2023-00104 · MDR key 17043383
Device
Generic name
Hip Component
Manufacturer
Microport Orthopedics Inc.Model number
PHA01254Catalog number
PHA01254
Lot number
039831013
Product problems
- Break
- Break
Patient
Unknown
- Pain
- Insufficient Information
- Pain
- Insufficient Information
Narrative
Description of Event or Problem
ALLEGEDLY, MODULAR NECK FRACTURE LEFT HIP. ADDITIONAL INFORMATION RECEIVED ON 2023-07-06: THE PATIENT SUDDENLY FELT PAIN IN THE AREA OF THE LEFT HIP WITHOUT TRAUMA SINCE THEN HE CAN NO LONGER PUT FULL WEIGHT ON THE LEFT HIP. NON-MPO COMPONENTS: PRODUCT ID: 0805M8N0158 IMPLANTEC GMBH OF GRENZGASSE 38A, 2340 MÖDLING/ LOT NUMBER: 90621-A/ QTY: (B)(4).
Description of Event or Problem
ALLEGEDLY, MODULAR NECK FRACTURE LEFT HIP. IT IS NOT MENTIONED ON INITIAL REPORT IF A REVISION SURGERY HAS ALREADY BEEN PERFORMED. A DEVICE WITH LOT NUMBER: 0805MSN0158 HAS BEEN INDICATED TO BE RELATED TO THIS EVENT HOWEVER THIS LOT NUMBER DOES NOT CORRESPOND TO AN ACTUAL MICROPORT ORTHOPEDICS PRODUCT.
Remedial action
- Recall