Quadra R femoral stems 01.12.060Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630030802386), received between Apr 25, 2024 and Mar 3, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 3, 2026Osseointegration Problem

  THE PATIENT WAS EVALUATED ON AN OUTPATIENT BASIS FOR LEFT HIP PAIN AND CRURALGIA FOLLOWING MULTIPLE REVISION SURGERIES OF THE LEFT TOTAL HIP ARTHROPLASTY. APPROXIMATELY 7 YEARS AND 7 MONTHS AFTER THE PRIMARY, A REVISION SURGERY WAS PERFORMED DUE TO STEM LOOSENING.THE SURGEON REMOVED THE STEM, THE HEAD, AND TWO METALLIC CERCLAGE WIRE FRAGMENTS AT THE FEMORAL SITE. THIS WAS FOLLOWED BY REIMPLANTATION OF A NON-CEMENTED MODULAR CONICAL STEM AND A CERAMIC FEMORAL HEAD, AS WELL AS FIXATION OF THE CORTICAL WINDOW USING THE SUPERCABLE CERCLAGE SYSTEM BY KINAMED.

  Patient problems: Aseptic loosening; Inadequate Osseointegration

  MAUDE report 24494914 ↗
• InjuryApr 25, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2021. ON (B)(6) 2023, THE PATIENT CAME IN REPORTING PAIN DUE TO A FRACTURED FEMUR THAT WAS CAUSED FROM FALLING. THE SURGEON REVISED SUCCESSFULLY THE HEAD AND STEM. ON (B)(6) 2024, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED SUCCESSFULLY THE HEAD AND LINER. PRESENTLY, ON (B)(6) 2024, THE PATIENT CAME IN DUE TO A PERIPROSTHETIC FRACTURE AND THE CASE IS UNKNOWN. THE SURGEON REVISED THE STEM AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 19178587 ↗

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