RECAP HIP SYSTEM
Received Jun 12, 2026 · Event occurred Nov 6, 2017
Report 0001825034-2026-01735 · MDR key 25488346
Device
Generic name
Prosthesis, Hip, Femoral, Resurfacing
Manufacturer
Zimmer Biomet, Inc.Catalog number
US157250
Lot number
628760
Product problems
- Material Erosion
Patient
NA · Male
- Pain
- Seroma
- Synovitis
- Ambulation or Postural Difficulties
- Metal Related Pathology
- Muscle/Tendon Damage
- Unequal Limb Length
- High metal ion levels
Narrative
Additional Manufacturer Narrative
(B)(4). D10: UNK DEPUY CEMENT. G2: FOREIGN ¿ EVENT OCCURRED IN CANADA. H6: PROPOSED COMPONENT CODE: MECHANICAL (G04) - HEAD. 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 3500A WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT APPROXIMATELY 11 YEARS POST-IMPLANTATION, THE PATIENT UNDERWENT A LEFT HIP REVISION DUE TO ANTALGIC GAIT, + TRENDELENBURG SIGN, PAIN, LEG LENGTH DISCREPANCY 3-4MM, ALTR, ELEVATED METAL IONS. DURING THE REVISION NOTED A LARGE AMOUNT OF FLUID, SEROMA, AND SYNOVITIS. CONVERTED HIP RESURFACING TO TOTAL HIP. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.