Quadra H femoral stems 01.12.21SNRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 07630030802614), received between Oct 19, 2017 and Jun 17, 2026 — classified as 18 injuries.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (4 reports).

1 other recall cover devices cleared under the same FDA submission (K082792, K250450); 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryJun 17, 2026Implant subsidence

  REVISION SURGERY WAS PERFORMED ABOUT 8 YEARS AND 9 MONTHS AFTER THE PRIMARY SURGERY FOLLOWING A TRAUMATIC LEFT PROXIMAL FEMORAL FRACTURE, SUBSEQUENT HIP DISLOCATION, AND FURTHER STEM SUBSIDENCE/LOOSENING/RETROVERSION. ACCORDING TO THE REVISION SURGEON, SIGNS OF STEM SUBSIDENCE WERE ALREADY PRESENT PRIOR TO THE TRAUMA. ALL COMPONENTS WERE REVISED TO A COMPETITOR SYSTEM.

  Patient problems: Implant Pain

  MAUDE report 25528761 ↗
• InjuryMar 3, 2026Osseointegration Problem

  AT ABOUT 12 YEAR AND 11 MONTH FROM THE PRIMARY,THE PATIENT CAME REPORTING HIPPAIN DUE TO EVIDENT STEM LOOSENING.DURING THE REVISION SURGERY, THE HEAD, STEM, AND LINER WERE REMOVED, WHILE THE CUP WAS RETAINED.

  Patient problems: Aseptic loosening; Inadequate Osseointegration

  MAUDE report 24494918 ↗
• InjuryDec 2, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 4 YEARS AND 9 MONTHS FROM PRIMARY, THE PATIENT CAME IN DUE TO A METAL ALLERGY. THE SURGEON REVISED THE MEDACTA STEM, CUP, AND LINER TO A COMPETITOR STEM CUP AND LINER AND REVISED THE MEDACTA HEAD TO A MEDACTA HEAD WITH SLEEVE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Metal Related Pathology

  MAUDE report 23690785 ↗
• InjuryJun 12, 2025Migration; Migration

  AT ABOUT 3 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A SUBSIDED STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE STEM AND HEAD WITH COMPETITOR COMPONENTS AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER.

  Patient problems: Implant Pain

  MAUDE report 22194002 ↗
• InjuryJun 4, 2024Osseointegration Problem; Osseointegration Problem

  AT ABOUT 7 YEARS AND 9 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE OF THE LOOSE STEM IS UNKNOWN. THE SURGEON REVISED THE MEDACTA STEM WITH A COMPETITOR STEM AND THE MEDACTA LINER WITH A NEW MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 19457187 ↗
• InjuryDec 19, 2023Failure to Osseointegrate; Failure to Osseointegrate

  AT ABOUT 8 YEARS AND 11 MONTHS FROM THE PRIMARY, THE PATIENT'S X-RAYS SHOWED THICKENING OF THE CORTICAL WALLS AT THE DISTAL PART OF THE STEM WHICH IS CAUSED BY THE STEM BEING LOOSE. THE SURGEON REMOVED THE COCR HEAD, THE QUADRA-H STEM AND REPLACED IT WITH A ZIMMER STEM. SURGERY COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18354766 ↗
• InjuryApr 12, 2023Osseointegration Problem; Osseointegration Problem

  REVISION SURGERY DUE TO STEM LOOSENING. AT ABOUT 7 YEARS AND 11 MONTHS FROM PRIMARY THE SURGEON SWAPPED SUCCESSFULLY THE STEM AND HEAD.

  Patient problems: Inadequate Osseointegration

  MAUDE report 16722678 ↗
• InjuryJun 1, 2021Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT CAME IN REPORTING PAIN DUE TO A SUBSIDED STEM AND THE CAUSE OF THE SUBSIDED STEM IS UNKNOWN. THE SURGEON REVISED THE STEM, HEAD, AND LINER 3 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 11911478 ↗
• InjuryJul 13, 2020Loose or Intermittent Connection

  THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM. 2 YEARS AND 10 MONTHS THE SURGEON REVISED THE STEM AND HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 10263650 ↗
• InjuryDec 19, 2019Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED, 10 MONTHS AFTER PRIMARY SURGERY, DUE TO PAIN. STEM HAS BEEN SUCCESSFULLY REMOVED.

  Patient problems: Joint Disorder

  MAUDE report 9493949 ↗
• InjuryNov 13, 2019Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY PERFORMED 5 YEARS AND 2 MONTHS AFTER THE PRIMARY DUE TO STEM LOOSENING. THE STEM AND THE BALL HEAD HAVE BEEN REVISED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9314609 ↗
• InjuryAug 9, 2019Adverse Event Without Identified Device or Use Problem

  SECOND REVISION SURGERY PERFORMED AFTER ONE MONTH FROM THE FIRST REVISION DUE TO AN INFECTION (THE PATHOGEN IS UNKNOWN). THE SURGEON REVISED THE HEAD, STEM, CUP, AND LINER, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. DURING THE FIRST REVISION SURGERY ALSO CAUSED BY INFECTION, THE STEM, CUP, AND LINER HAVE BEEN REVISED.

  Patient problems: Unspecified Infection

  MAUDE report 8878381 ↗
• InjuryJun 28, 2019Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED AFTER ABOUT 2 YEARS FROM THE PRIMARY DUE TO HIP STEM SINKING. THE SURGERY WAS COMPLETED SUCCESSFULLY, ALL DEVICES REVISED.

  Patient problems: Joint Disorder

  MAUDE report 8743233 ↗
• InjuryFeb 6, 2019Device Slipped

  REVISION SURGERY PERFORMED, 4 YEARS AND 2 MONTHS AFTER PRIMARY SURGERY, DUE TO PAIN AND STEM LOOSENING. THE SURGEON REVISED THE IMPLANT WITH A CEMENTED STEM.

  Patient problems: Pain

  MAUDE report 8310177 ↗
• InjuryDec 14, 2018Loose or Intermittent Connection

  REVISION SURGERY PERFORMED DUE TO STEM LOOSENING (RIGHT SIDE). THE STEM WAS REMOVED AND REPLACED WITH A COMPETITOR STEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8164772 ↗
• InjuryOct 24, 2018Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY PERFORMED DUE TO INFECTION 1 MONTH AFTER PRIMARY. THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED THE STEM, HEAD AND LINER SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 7999389 ↗
• InjuryDec 29, 2017Loose or Intermittent Connection

  THE PATIENT HAD PAIN 14 MONTHS AFTER PRIMARY. DURING THE REVISION SURGERY IT WAS NOTICED THAT THE STEM HAD LOOSENED.

  Patient problems: Joint Dislocation

  MAUDE report 7153833 ↗
• InjuryOct 19, 2017Loose or Intermittent Connection

  PATIENT HAD A LOOSE FEMORAL STEM REQUIRING REVISION. THE STEM WAS REMOVED EASILY, THE SURGEON REMOVED THE BONE FROM THE SHOULDER OF THE IMPLANT AND USED THE SCREW EXTRACTOR TO TAP OUT THE STEM. THERE WAS LITTLE SIGN OF O GROWTH AND HE OBSERVED THAT THE STEM MAY HAVE BEEN UNDERSIZED.

  Patient problems: Joint Disorder

  MAUDE report 6961438 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K082792, K250450. One submission often covers many models, so check the product and lot details in each record.

• Z-0791-2013 · Dec 17, 2012 · Terminated
  Medacta Quadra Trial Broach size 0 part # 01.10.10.045, for use with the Medacta Total Hip Prosthesis System. Product Usage - used to broach the intramedullary canal of the femur