NA 6624-65-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00889024127661), received between Aug 7, 2023 and Dec 15, 2025 — classified as 7 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryDec 15, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

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

  Patient problems: Aseptic loosening

  MAUDE report 23811712 ↗
• InjuryNov 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT HAD AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY FOLLOWED BY A REVISION FIVE MONTHS POST-OPERATIVE DUE TO THREE RECURRENT DISLOCATIONS. A SECOND REVISION WAS PERFORMED APPROXIMATELY 9 YEARS DUE TO PAIN AND OSSIFICATION. TWO MONTHS POST-SECOND REVISION, PATIENT UNDERWENT A DAIR FOR WOUND DEHISCENCE A THIRD REVISION DUE TO RECURRENT DISLOCATIONS. FOLLOWING THE REVISION, EXPERIENCED EXCRUCIATING PAIN DUE A FRACTURED ACETABULAR SCREW AND UNDERWENT A FOURTH REVISION. DURING THE PROCEDURE, THE PATIENT REPORTS, THE CONSTRUCT FELL PART IN THE SURGEONS AND THE GLUTEUS MUSCLES WERE DAMAGE. SUBSEQUENTLY, FOLLOWING THE PROCEDURE, THE RIGHT QUAD MUSCLE IS NOT FIRING, LEADING TO AN INABILITY TO WALK. THE PATIENT IS ALLEGING THAT DURING THE FOURTH REVISION, A NERVE WAS FLATTENED FROM EITHER THE FRACTURED SCREW OR THE PROCEDURE. NERVE CONDUCTION STUDIES HAVE BEEN PERFORMED AND IDENTIFIED FEMORAL NEUROPATHY. ALL IMPLANTS REMAIN IMPLANTED AT THIS TIME AND THEN PATIENT IS PLANNING TO BE ADMITTED TO AN INPATIENT REHABILITATION CENTER FOR AN INTENSE REHAB PROGRAM. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Ambulation or Postural Difficulties; Nerve Damage; Neuropathy

  MAUDE report 23543844 ↗
• InjuryNov 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

  Patient problems: Ambulation or Postural Difficulties; Nerve Damage; Neuropathy

  MAUDE report 23543842 ↗
• InjuryMar 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BILATERAL HIP REVISION APPROXIMATELY ONE YEAR AND THREE MONTHS POST IMPLANTATION DUE TO AN ACETABULAR FRACTURE. THE SHELLS, SCREWS AND HEADS WERE REMOVED AND REPLACED. IT WAS REPORTED THAT NO ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Bone Fracture(s)

  MAUDE report 21584291 ↗
• 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 20835673 ↗
• InjuryJan 8, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION APPROXIMATELY THREE YEARS POST IMPLANTATION DUE TO A LOOSE CUP. DURING THE REVISION SURGERY, IT WAS NOTED THAT THE AUGMENT WAS WELL FIXED AND THE STEM WAS STABLE. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 18468079 ↗
• InjuryAug 7, 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 17471395 ↗

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-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-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-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-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-1025-2014 · Oct 11, 2013 · Terminated
  HGP II ACETABULAR CUP BON
• Z-1036-2014 · Oct 11, 2013 · Terminated
  CPT DEGREE TAPER (various sizes) and FEMORAL HD (various sizes)
• Z-1026-2014 · Oct 11, 2013 · Terminated
  HGP II ACETABULAR CUP MOD
• Z-1033-2014 · Oct 11, 2013 · Terminated
  6 DEGREE COCR FEM HEAD (various sizes) and 6 DEG UNIPOLAR FEMORAL HE