Quadra H femoral stems 01.12.33SNRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07630030802737), received between Feb 20, 2018 and Dec 18, 2025 — classified as 6 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryDec 18, 2025Osseointegration Problem; Osseointegration Problem

  ON (B)(6) 2018, THE PATIENT HAD PRIMARY RIGHT HIP SURGERY. ON (B)(6) 2019, THE PATIENT CAME IN COMPLAINING OF PAIN CAUSED BY A LOOSE STEM. THE SURGEON REVISED THE STEM AND HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY (MDR (B)(4)). PRESENTLY, ON (B)(6) 2025, THE PATIENT CAME IN DUE TO PAIN CAUSED BY A LOOSE STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE MEDACTA HEAD AND STEM TO A COMPETITOR HEAD AND STEM AND REVISED THE MEDACTA LINER TO A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening; Inadequate Osseointegration

  MAUDE report 23836915 ↗
• InjuryMay 25, 2023Failure to Osseointegrate; Failure to Osseointegrate

  REVISION SURGERY PERFORMED AT ABOUT 5 YEARS AND 10 MONTHS AFTER PRIMARY DUE TO ASEPTIC STEM LOOSENING. THE SURGEON REVISED SUCCESSFULLY THE MEDACTA HEAD AND STEM.

  Patient problems: Inadequate Osseointegration

  MAUDE report 17000835 ↗
• InjuryApr 13, 2021Positioning Problem

  THE PATIENT CAME IN FOR PRIMARY HIP SURGERY ON (B)(6) 2021. DURING POST-OP RECOVERY, THE SURGEON REVIEWED POST-OP X-RAYS THAT INDICATED THE PATIENT HAD TOO MUCH OFFSET. THE SURGEON DECIDED TO REVISE THE STEM AND HEAD ON THE SAME DAY OF PRIMARY SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY. QUADRA H SN STANDARD HAS BEEN IMPLANTED.

  Patient problems: Insufficient Information

  MAUDE report 11654727 ↗
• InjuryApr 7, 2020Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT HAD A PRIMARY SURGERY AND WAS IMPLANTED WITH COMPETITOR COMPONENTS. ON (B)(6) 2020, THE PATIENT CAME IN REPORTING PAIN. THE CAUSE OF THE PAIN IS UNKNOWN. THE SURGEON REVISED THE COMPETITOR HEAD AND STEM WITH A MEDACTA HEAD AND STEM. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2020, THE PATIENT CAME IN FOR A POST-OP APPOINTMENT AND THE SURGEON OBSERVED THE PATIENT HAD SUPERFICIAL WOUND DRAINAGE. THE SURGEON PERFORMED A WASHOUT AND OBSERVED THAT THE PATIENT'S STEM WAS LOOSE AND THAT NOTHING COULD BE REVISED ANTERIORLY. THE PATIENT WAS CLOSED AND THE SURGEON REVISED THE PATIENT AGAIN ON (B)(6) 2020 USING THE POSTERIOR APPROACH. THE SURGEON REMOVED THE MEDACTA STEM AND HEAD, AND THE COMPETITOR CUP AND LINER, AND REVISED THEM WITH OTHER COMPETITOR COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY, 3 WEEKS AFTER PRIMARY SURGERY.

  Patient problems: Joint Disorder

  MAUDE report 9932414 ↗
• InjuryDec 10, 2019Loosening of Implant Not Related to Bone-Ingrowth

  THE SURGEON INFORMED ME THAT THE PATIENT RETURNED WITH PAIN ON THE RIGHT SIDE- IMAGING INVESTIGATION SHOWED THE STEM APPEARED LOOSE. REVISION SURGERY VIA POSTERIOR APPROACH 4 YEARS AND 11 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 9443535 ↗
• InjuryFeb 20, 2018Insufficient Device Problem Information

  REVISION DUE TO SIGNS OF INFECTION 1 YEAR AND 2 MONTHS AFTER PRIMARY. CUP AND LINER REPLACED WITH MEDACTA HARDWARE, WHILE STEM AND HEAD WITH ANOTHER COMPANY'S PRODUCTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 7281754 ↗

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