NA 6624-65-40Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00889024127685), received between Feb 24, 2020 and Dec 3, 2024 — classified as 6 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (5 reports).

9 other recalls cover devices cleared under the same FDA submission (K840643, K921308); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryDec 3, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 16 MONTHS LATER DUE TO ACETABULAR LOOSENING. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 20835602 ↗
• InjuryAug 5, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Failure of Implant; Pain

  MAUDE report 19906435 ↗
• InjuryDec 18, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY TWO YEARS AFTER A SECOND STAGE REVISION DUE TO ACETABULAR LOOSENING. THE HEAD, SHELL, LINER, AND AUGMENT WERE REPLACED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant; Osteopenia/ Osteoporosis

  MAUDE report 18344590 ↗
• InjuryAug 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP PROCEDURE. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION APPROXIMATELY 1 YEAR LATER DUE TO BONE LOSS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Osteopenia/ Osteoporosis

  MAUDE report 17452846 ↗
• InjuryFeb 24, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 17 MONTHS POST IMPLANTATION, THE PATIENT WAS REVISED DUE TO LOOSENING OF THE ACETABULAR COMPONENTS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Rheumatoid Arthritis

  MAUDE report 9746233 ↗
• InjuryFeb 24, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 17 MONTHS POST IMPLANTATION, THE PATIENT WAS REVISED DUE TO LOOSENING OF THE ACETABULAR COMPONENTS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Rheumatoid Arthritis

  MAUDE report 9746230 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K840643, K921308. One submission often covers many models, so check the product and lot details in each record.

• Z-1683-2016 · May 4, 2016 · Terminated
  Hgp ii acetabular cup bone screw selftap 6.5x15mm 00662406515 Hgp ii acetabular cup bone screw selftap 6.5x20mm 00662406520 Hgp ii acetabular cup bone screw selftap 6.5x25mm 006624
• Z-1137-2016 · Jan 11, 2016 · Terminated
  Product 39 consists of all product under product code: JDI and same usage: Item no: 32902605800 ION IMPLANTED FEM 22MM LO 32902604900 ION IMPLANTED FEM 26MM ME 32902603900 ION IM
• Z-1126-2016 · Jan 11, 2016 · Terminated
  Product 28 consists of all product under product code: JDI and same usage: Item no: 32902605000 FEMORAL HD 28MM MEDIUM 32902604000 FEMORAL HD 28MM SHORT 32902604035 FEMORAL HD 28M
• Z-1131-2016 · Jan 11, 2016 · Terminated
  Product 33 consists of all product under product code: JDI and same usage: Item no: 662406515 HGP II ACETABULAR CUP BON 662406520 HGP II ACETABULAR CUP BON 662406525 HGP II ACETA
• Z-1110-2016 · Jan 11, 2016 · Terminated
  Product 12 consists of all product under product code JDI , and same usage: Item no: 902602935 6 DEGREE COCR FEM HEAD 28 902602835 6 DEGREE COCR FEM HEAD 28 902603235 6 DEGREE COC
• Z-1036-2014 · Oct 11, 2013 · Terminated
  CPT DEGREE TAPER (various sizes) and FEMORAL HD (various sizes)
• Z-1033-2014 · Oct 11, 2013 · Terminated
  6 DEGREE COCR FEM HEAD (various sizes) and 6 DEG UNIPOLAR FEMORAL HE
• Z-1026-2014 · Oct 11, 2013 · Terminated
  HGP II ACETABULAR CUP MOD
• Z-1025-2014 · Oct 11, 2013 · Terminated
  HGP II ACETABULAR CUP BON