Quadra H femoral stems 01.12.22SNRecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 07630030802621), received between Jun 27, 2017 and Mar 19, 2025 — classified as 16 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (5 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 19, 2025Osseointegration Problem; Osseointegration Problem

  THE PATIENT HAS MODERATE PAIN AND PRESENTS SIGNS OF LOOSENING/STRESS SHIELDING. NO REVISION SURGERY IS PLANNED.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 21640394 ↗
• InjuryJul 26, 2024Failure to Osseointegrate; Failure to Osseointegrate

  AT ABOUT 9 YEARS 8 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND COMPETITOR'S CUP AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE MEDACTA STEM AND HEAD WITH A COMPETITOR STEM AND HEAD AND REVISED THE COMPETITOR CUP AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 19836131 ↗
• InjuryNov 3, 2023Osseointegration Problem; Osseointegration Problem

  REVISION SURGERY AT ABOUT 6 YEARS AND 11 MONTHS POST-PRIMARY DUE TO STEM LOOSENING. THE STEM, HEAD AND LINER HAVE BEEN REVISED. NO PROBLEM WERE AT LINER AND HEAD LEVEL.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18063839 ↗
• InjuryMar 25, 2021Loose or Intermittent Connection; Loss of Osseointegration

  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 AND HEAD WITH A COMPETITOR STEM AND HEAD AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER 7 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11568319 ↗
• InjuryMar 17, 2021Difficult to Remove; Malposition of Device

  3 MONTHS AFTER THE PRIMARY SURGERY THE STEM SUBSIDED AND IT SHOULD HAVE BEEN REVISED BUT THE SURGEON COULD NOT EXTRACT IT EVEN AFTER CONSIDERABLE EFFORT. THE STEM REMAINED IN SITU AND A BIGGER HEAD WAS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 11504350 ↗
• InjuryMar 16, 2021Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING PAIN. POST-OP X-RAYS REVEALED THAT THE STEM POTTED DISTALLY. THE SURGEON REVISED THE STEM AND HEAD AND ADDED A SLEEVE 3 YEARS 2 MONTHS AFTER THE PRIMARY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11493346 ↗
• InjuryJan 15, 2021Migration or Expulsion of Device

  REVISION SURGERY PERFORMED AFTER 6 YEARS FROM THE PRIMARY SURGERY DUE TO THIGH PAIN & GROIN PAIN ASSOCIATED WITH RADIOLUCENT LINES AROUND THE FEMORAL COMPONENT. REVISION COMPLETED VIA A POSTERIOR APPROACH. THE STEM AND CUP WERE WELL FIXED. TRUNIONOSIS NOTED BY THE SURGEON.

  Patient problems: Osteolysis; Pain

  MAUDE report 11177765 ↗
• InjuryJul 17, 2020Loose or Intermittent Connection

  THE PATIENT WAS APPROXIMATELY 3 YEARS OF POST-PRIMARY REPLACEMENT (2017) CAME BACK TO THE SURGEON WITH COMPLAINTS OF PAIN. THE STEM WAS FOUND TO BE LOOSE PROXIMALLY BUT WELL FIXED DISTALLY. THE SURGEON STATED THE PATIENT HAD BEEN WATER SKIING ON THEIR REPLACEMENT.

  Patient problems: Inadequate Osseointegration

  MAUDE report 10288602 ↗
• InjuryDec 3, 2019Migration; Migration

  REVISION SURGERY 5 YEARS AFTER THE PRIMARY DUE TO STEM SUBSIDENCE. THE QUADRA STEM WAS REMOVED VIA A POSTERIOR APPROACH, THE SURGEON COMMENTED THAT IT HAD NOT BONDED. A MINIMAX STEM WAS USED TO COMPLETE THE REVISION SURGERY WITH A NEW CERAMIC HEAD. A SMALL AMOUNT OF BONE GRAFT DISTALLY WAS ALSO USED.

  Patient problems: No Information

  MAUDE report 9400844 ↗
• InjuryOct 25, 2019Loose or Intermittent Connection

  REVISION FOLLOWING THE LOOSENING OF THE STEM 8 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 9237117 ↗
• InjuryJul 10, 2019Loose or Intermittent Connection

  TWO DAYS AFTER PRIMARY SURGERY, THE STEM WAS REVISED DUE TO SUBSIDENCE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 8775238 ↗
• InjuryDec 14, 2018Loose or Intermittent Connection; Patient-Device Incompatibility

  THE PATIENT CAME IN COMPLAINING OF PAIN 4 YEARS AND 8 MONTHS AFTER THE PRIMARY. THE STEM WAS LOOSE AND MICRO MOVEMENT HAD CAUSED HETEROTOPIC OSSIFICATION.

  Patient problems: Inadequate Osseointegration

  MAUDE report 8164773 ↗
• InjuryNov 7, 2018Device Slipped

  REVISION SURGERY PERFORMED 5 YEARS AFTER PRIMARY DUE TO INTERMITTENT SHARP THIGH PAIN. DURING SURGERY IT WAS DISCOVERED THAT THE STEM WAS BONDED DISTALLY AND LOOSE PROXIMALLY. STEM AND BALL HEAD WERE REVISED.

  Patient problems: Joint Disorder

  MAUDE report 8045562 ↗
• InjuryAug 17, 2017Fracture

  AFTER PRIMARY SURGERY, IT WAS NOTICED THAT THE FEMUR HAD BEEN FRACTURED: STEM, HEAD AND LINER REVISED IN AMIS APPROACH ON THE FOLLOWING DAY WITH ITEMS OF THE SAME REFERENCES. MOREOVER, THE SURGEON ADDED 2 SCREWS TO SECURE THE CUP MORE.

  Patient problems: Bone Fracture(s)

  MAUDE report 6800232 ↗
• InjuryAug 3, 2017Device Operates Differently Than Expected

  REVISION SURGERY 1 MONTH AFTER PRIMARY DUE TO BONE FRACTURE AND STEM SUBSIDENCE. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 6763328 ↗
• InjuryAug 3, 2017Adverse Event Without Identified Device or Use Problem

  REVISION OF ALL THE IMPLANTS DUE TO SUSPECTED INFECTION 1 YEAR AND 1 MONTH AFTER PRIMARY. THE SURGEON IMPLANTED A STEM AND DM LINER AND METAL HEAD DURING THE FIRST STEP OF THE REVISION SURGERY, AS THERE WAS NOT ANY CEMENT SPACERS AVAILABLE AT THE HOSPITAL. NO CUP WAS IMPLANTED. WHEN THE INFECTION IS CLEARED THESE COMPONENTS WILL BE REMOVED AND THE DEFINITIVE ONES IMPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 6762725 ↗
• InjuryJun 27, 2017Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN COMPLAINING OF PAIN. THE PATIENT FRACTURED HER FEMUR WHILE WALKING. THE SURGEON DETERMINED THE PATIENT HAD POOR BONE QUALITY. THE SURGEON SWAPPED THE BIPOLAR HEAD, COCR HEAD AND THE STEM. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 6669388 ↗

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