Quadra H femoral stems 01.12.025Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 07630030802065), received between Jan 4, 2018 and Aug 8, 2025 — classified as 16 injuries.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (3 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryAug 8, 2025Break; Break

  REVISION SURGERY PERFORMED DUE TO STEM NECK BREAKAGE AFTER ABOUT 6 YEARS AND 5 MONTHS. THE PATIENT HAD AN INTERMEDIATE SURGERY BETWEEN THE PRIMARY AND THE REVISION OF (B)(6) 2025 (DATE UNKNOWN, REASON UNKNOWN) IN WHICH THE HEAD HAS BEEN REVISED. WE HAVE THIS EVIDENCE BECAUSE THE REVISED HEAD ON (B)(6) 2025 IS A REVISION HEAD; WE DON'T KNOW IF OTHER IMPLANTS WERE REVISED.

  Patient problems: Insufficient Information

  MAUDE report 22749123 ↗
• InjurySep 11, 2024Loss of Osseointegration; Migration; Loss of Osseointegration; Migration

  AT ABOUT 10 YEARS AND 9 MONTHS AFTER PRIMARY, THE PATIENT HAS BEEN REVISED BECAUSE OF STEM SUBSIDENCE AND SUBSEQUENT LOOSENING. STEM AND BALL HEAD REVISED SUCCESSFULLY AND REPLACED WITH S&N REDAPT STEM AND OXINUM HEAD.

  Patient problems: Inadequate Osseointegration

  MAUDE report 20188938 ↗
• InjuryFeb 24, 2023Migration; Migration

  ON (B)(6) 2022 THE PATIENT HAD A PRIMARY HIP SURGERY. AFTER THE PRIMARY, THE PATIENT SUFFERED A TRAUMA RESULTING IN A BONE FEMORAL FRACTURE, WHICH WAS NOT TREATED SURGICALLY. PRESENTLY, ON (B)(6) 2023, THE PATIENT WAS REVISED BECAUSE OF THE SUBSIDED STEM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16435257 ↗
• InjurySep 7, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY AT ABOUT 12 YEARS AND 11 MONTHS FOR FEMUR OSTEOLYSIS. THE SURGEON REVISED THE STEM HEAD AND LINER SUCCESSFULLY.

  Patient problems: Osteolysis

  MAUDE report 15370485 ↗
• InjurySep 7, 2022Failure to Osseointegrate; Failure to Osseointegrate

  AT ABOUT 3 YEARS AND 11 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT WAS REVISED BECAUSE OF STEM LOOSENING. THE SURGERY WAS COMPLETED SUCCESSFULLY BY IMPLANTING A QUADRA C STEM THROUGH A POSTERIOR APPROACH.

  Patient problems: Inadequate Osseointegration

  MAUDE report 15368479 ↗
• InjuryMar 18, 2022Loosening of Implant Not Related to Bone-Ingrowth

  AT 1 YEAR 9 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND SUSPECTED IMPINGEMENT. THE SURGEON REVISED THE STEM (QUADRA-H TO QUADRA R), HEAD, AND LINER.

  Patient problems: Inadequate Osseointegration

  MAUDE report 13803788 ↗
• InjuryJul 26, 2021Loose or Intermittent Connection

  REVISION SURGERY PERFORMED 12 YEARS 2 MONTHS AFTER THE PRIMARY DUE TO STEM LOOSENING WITH SUPPOSED INFECTION. THE SURGEON DECIDED TO REMOVE ALL THE IMPLANTS AND IMPLANT A NEW HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 12223761 ↗
• InjuryMar 16, 2021Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED 8 YEARS AND 5 MONTHS AFTER THE PRIMARY SURGERY DUE TO STEM MOBILIZATION. THE LINER, HEAD AND STEM WERE REVISED. NO SIGN OF INFECTION PRESENT, THE STEM WAS EASILY REMOVED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11492688 ↗
• InjuryDec 14, 2020Appropriate Device Problem Term/Code Not Available

  THE SURGEON PERFORMED A REVISION THR (14 DAYS AFTER PRIMARY SURGERY) DUE TO A PROXIMAL FEMORAL FRACTURE OCCURRING POST OPERATIVELY. THE PRIMARY STEM WAS REMOVED, THE FRACTURE WAS CABLED & A QUADRA C STEM WAS IMPLANTED USING PALACOS CEMENT. THE CUP AND LINER WERE NOT REMOVED.

  Patient problems: Bone Fracture(s)

  MAUDE report 11001861 ↗
• InjuryJun 12, 2020Device Slipped

  THE PATIENT DISLOCATED IN THE HOSPITAL AND AFTER FURTHER INVESTIGATION WITH X-RAY IT WAS DISCOVERED SUBSIDENCE OF THE FEMORAL COMPONENT, THE SURGEON SUSPECTS THAT DURING THE PRIMARY SURGERY 8 DAYS BEFORE OCCURRED A BONE FRACTURE, BUT IT IS NOT CONFIRMED IF THE FRACTURE OCCURRED DURING OF AFTER THE PRIMARY SURGERY. THE SURGEON REVISED THE STEM AND HEAD AND CABLED THE FRACTURE.

  Patient problems: Hip Fracture

  MAUDE report 10147233 ↗
• InjuryApr 1, 2020Appropriate Device Problem Term/Code Not Available

  PATIENT HAD ORIGINAL ANTERIOR HIP REPLACEMENT ON (B)(6) 2018, NO ISSUES UNTIL 3 MONTHS AGO, WHEN HE RETURNED TO DR WITH PAIN. AFTER XRAY'S AND BIOPSY, INFECTION WAS CONFIRMED IN FEMUR. ALL IMPLANTS REMOVED 1 YEAR AND A HALF AFTER PRIMARY FOR STAGE 1 REVISION.

  Patient problems: Unspecified Infection

  MAUDE report 9909610 ↗
• InjuryMar 18, 2020Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED 1 YEAR AND 4 MONTHS AFTER PRIMARY SURGERY DUE TO INFECTION. ALL IMPLANTS SUCCESSFULLY REVISED.

  Patient problems: Unspecified Infection

  MAUDE report 9847173 ↗
• InjuryMar 4, 2020Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT RETURNED TO THE HOSPITAL FOR REVIEW, PAIN IN THE HIP. STEM LOOSENING WAS DETECTED THEREFORE REQUIRING REVISION SURGERY 6 YEARS AND 5 MONTHS AFTER "PRMARY". THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 9785489 ↗
• InjuryFeb 21, 2020Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED DUE TO PAIN AND NOT OSSEOINTEGRATION OF THE STEM AFTER ABOUT 2 YEARS FROM THE PRIMARY SURGERY.

  Patient problems: Joint Disorder

  MAUDE report 9738112 ↗
• InjuryNov 22, 2019Loose or Intermittent Connection

  REVISION SURGERY PERFORMED 3 YEARS AND 8 MONTHS AFTER PRIMARY SURGERY DUE TO STEM LOOSENING.

  Patient problems: Joint Disorder

  MAUDE report 9362907 ↗
• InjuryJan 4, 2018Loose or Intermittent Connection

  THREE YEARS AFTER PRIMARY THE SURGEON DETECTED A STEM LOOSENING AND REVISED THE PATIENT. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 7163362 ↗

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