Quadra H femoral stems 01.12.024Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 07630030802058), received between Nov 30, 2017 and Dec 24, 2025 — classified as 24 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (6 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 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• InjuryDec 24, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD HIP PAIN AND INFECTION. THE X-RAY SUGGESTED SEPTIC LOOSENING OF THE STEM. AT ABOUT 9 YEARS AND 11 MONTHS POST PRIMARY REVISION PERFORMED AND THE STEM WAS REMOVED WITH VERY MINIMAL EFFORT.

  Patient problems: Medical device site infection

  MAUDE report 23886575 ↗
• InjuryApr 29, 2025Loss of Osseointegration; Loss of Osseointegration

  REVISION OF STEM DUE TO LOOSENING. DATE OF PRIMARY IS UNKNOWN. NO ADDITIONAL DETAILS AVAILABLE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 21928712 ↗
• 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 21640391 ↗
• InjuryFeb 12, 2025Failure to Osseointegrate; Failure to Osseointegrate

  AT ABOUT 9 YEARS 9 MONTHS AFTER PRIMARY, THE PATIENT HAS BEEN REVISED BECAUSE OF ACETABULAR SHELL AND CEMENTLESS STEM LOOSENING. THE SURGEON REVISED SUCCESSFULLY ALL THE COMPONENTS.

  Patient problems: Inadequate Osseointegration

  MAUDE report 21364654 ↗
• InjuryJul 27, 2022Adverse Event Without Identified Device or Use Problem

  AT 13 YEARS 3 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND THE SURGEON DETERMINED THAT THE STEM MAY BE LOOSE. DURING THE SURGERY, THE STEM APPEARED TO BE WELL FIXED BUT NEEDED PROXIMAL BONE GRAFT. THE SURGEON REVISED THE HEAD AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 15112217 ↗
• InjuryJun 2, 2022Fracture; Loosening of Implant Not Related to Bone-Ingrowth

  DURING THE PRIMARY SURGERY, ON (B)(6) 2012, THE PATIENT SUSTAINED A PROXIMAL FEMORAL FRACTURE WHICH REQUIRED A PLATE 1-DAY POST-OP. PRESENTLY ON (B)(6) 2022, THE PATIENT HAD A FALL CAUSING A PERIPROSTHETIC FRACTURE OF THE PELVIS WHICH RESULTED IN THE LOOSENING OF THE CUP. THE SURGEON REVISED SUCCESSFULLY THE FEMORAL HEAD AND CUP WITH A COMPETITOR DUAL MOBILITY CUP. THE STEM WAS WELL FIXED AND WAS LEFT IN SITU.

  Patient problems: Bone Fracture(s)

  MAUDE report 14574005 ↗
• InjuryMar 16, 2022Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED 4 YEARS AND 9 MONTHS AFTER THE PRIMARY SURGERY DUE TO ASEPTIC LOOSENING OF THE STEM. HEAD AND STEM REVISED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 13790632 ↗
• InjuryNov 7, 2021Osseointegration Problem; Osseointegration Problem

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

  Patient problems: Insufficient Information

  MAUDE report 12759289 ↗
• InjuryMar 31, 2021Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  LOOSENING OF A QUADRA-H (4 STD) STEM AFTER 14 YEARS AND 7 MONTHS AFTER THE PRIMARY SURGERY. THE SURGEON REVISED THE STEM, HEAD AND INLAY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11593997 ↗
• InjuryFeb 5, 2021Osseointegration Problem; Osseointegration Problem

  REVISION SURGERY ABOUT 10 YEARS AND 9 MONTHS AFTER PRIMARY FOR STEM LOOSENING AND HIGH LEVEL OF SUSPICION OF CUP LOOSENING WITH ECCENTRIC POLYETHYLENE ABRASION.

  Patient problems: Insufficient Information

  MAUDE report 11284531 ↗
• InjuryJan 8, 2021Adverse Event Without Identified Device or Use Problem

  THE PATIENT PRESENTED TO THE HOSPITAL CLINIC WITH FEVER, 11 YEARS AFTER THE PRIMARY SURGERY. INFECTION OF THE HIP WAS FOUND. ALSO SHOULDER (COMPETITOR PRODUCT) WAS FOUND INFECTED. WASH OUT PERFORMED AND LINER AND HEAD REPLACEMENT. ALSO SHOULDER WASHED OUT AND REPLACED. PRIMARY IMPLANTS WERE WELL FIXED AND STABLE.

  Patient problems: Unspecified Infection

  MAUDE report 11138880 ↗
• InjuryJun 18, 2020Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAS PAIN ON THE FEMUR SIDE AND THE SPECT-CT SHOWS RED COLOURS ON THE FEMORAL STEM. THE PATIENT HAS AN ALLERGY OF TITANIUM, REASON WHY THE SURGEON MUST REVISE THE ALL PROSTHESIS. SAMPLES TAKEN DURING THE REVISION SURGERY SHOWED AN INFECTION. THE REVISION SURGERY WAS SUCCESSFULLY PERFORMED.

  Patient problems: Unspecified Infection

  MAUDE report 10167002 ↗
• InjuryMay 26, 2020Loosening of Implant Not Related to Bone-Ingrowth

  ASEPTIC LOOSENING OF A QUADRA H STEM AFTER 6 YEARS AND 2 MONTHS FROM THE PRIMARY. THE STEM, HEAD AND INSERT WERE CHANGED.

  Patient problems: Joint Disorder

  MAUDE report 10086354 ↗
• InjuryApr 24, 2020Appropriate Device Problem Term/Code Not Available

  INFORMATION RECEIVED FORM (B)(6) ON 16.07.2020; REVISION PERFORMED ON (B)(6) 2020. THE ACETABULAR COMPONENT WAS MALPOSITIONED CAUSING POSTERIOR SUBLUXATION. THE CUP WAS WELL FIXED & REMOVED. ANALYSIS OF THE PHOTO OF THE EXPLANT RECEIVED PERFORMED BY MEDACTA RND DEPARTMENT: FROM THE RECEIVED PHOTO IT IS POSSIBLE TO NOTE THE WEAR OF THE CERAMIC LINER AND SHELL IN THE RIM, DUE TO A CONTINUOUS IMPINGEMENT. IT IS NOT POSSIBLE TO DETERMINE WITH CERTAINTY THE ROOT CAUSE OF THE EVENT, BUT FROM THE RECEIVED INFORMATION THE SURGEON DECLARED THAT THE ACETABULAR COMPONENT WAS MALPOSITIONED.

  Patient problems: Joint Disorder

  MAUDE report 9994547 ↗
• InjuryDec 2, 2019Appropriate Device Problem Term/Code Not Available

  ABOUT 4 MONTHS AFTER PRIMARY REVISION SURGERY FOR INFECTION. ALL HARDWARE REVISED AND A SPACER IMPLANTED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 9393532 ↗
• InjuryJul 11, 2019Insufficient Device Problem Information

  ABOUT 8 YEARS AFTER PRIMARY REVISION SURGERY FOR STEM ASEPTIC LOOSENING. THE SURGEON REVISED SUCCESSFULLY THE STEM AND HEAD.

  Patient problems: No Code Available

  MAUDE report 8780215 ↗
• InjuryJun 27, 2019Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY PERFORMED, 3 YEARS AND 5 MONTHS AFTER PRIMARY SURGERY, DUE TO STEM LOOSENING. THE SURGERY WAS COMPLETED SUCCESSFULLY SWAPPING THE PATIENT STEM AND CERAMIC BALL HEAD.

  Patient problems: Inadequate Osseointegration

  MAUDE report 8739694 ↗
• InjuryJun 26, 2019Loose or Intermittent Connection

  REVISION SURGERY PERFORMED AFTER 2 YEARS AND 1 MONTH DUE TO STEM LOOSENING. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 8734043 ↗
• InjuryMar 13, 2019Loosening of Implant Not Related to Bone-Ingrowth

  3 YEARS AND 10 MONTHS AFTER PRIMARY SURGERY, REVISION SURGERY PERFORMED FOR INFECTION ((B)(6)) LIKELY CAUSING STEM LOOSENING. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 8416470 ↗
• InjuryDec 12, 2018Loose or Intermittent Connection

  REVISION SURGERY DUE TO STEM LOOSENING 2 YEARS AND 6 MONTHS AFTER THE PRIMARY. THE STEM WAS LOOSE AT HIS PROXIMAL PART, THE DISTAL PART WAS WELL INTEGRATED.

  Patient problems: Joint Disorder

  MAUDE report 8155014 ↗
• InjuryNov 27, 2018Naturally Worn

  ON (B)(6) 2018 WE WERE INFORMED THAT ON THE FOLLOWING DAY THE SURGEON WOULD HAVE REVISED THE PATIENT MORE THAN 11 YEARS AFTER PRIMARY SURGERY, DUE TO SUSPECTED FEMORAL OSTEOLYSIS AND PE WEAR. THE SURGEON REVISED THE STEM, THE HEAD AND THE LINER.

  Patient problems: Joint Disorder

  MAUDE report 8105808 ↗
• InjuryJul 20, 2018Loose or Intermittent Connection

  THE SURGEON TEMPLATED FOR A SIZE 4/5 QUADRA STD STEM AND BROACHED UP TO A SIZE 4 USING A STD LATERAL APPROACH SURGICAL TECHNIQUE. HE PERFORMED A TRIAL REDUCTION AND THEN DOUBLE CHECKED THE TORSIONAL AND LINEAL STABILITY PRIOR TO CALLING FOR THE DEFINITIVE STEM. UPON IMPLANTATION OF THE SIZE 4 STEM HE FOUND IT TO SUBSIDE APPROXIMATELY 1 CM. HE THEN REMOVED THE STEM AND BROACHED UP TO A SIZE 5 AND ULTIMATELY IMPLANTED THAT STEM WHICH SAT 3MM DEEPER THAN BROACHED. THE SURGEON FELT THAT IT WAS STABLE AND ACCEPTED THE POSITION.

  Patient problems: Failure of Implant

  MAUDE report 7706397 ↗
• InjuryFeb 20, 2018Device Slipped

  THE PATIENT CAME IN COMPLAINING OF INSTABILITY 7 YEARS AND 6 MONTHS AFTER PRIMARY: THE STEM WAS LOOSE. THE SURGEON REVISED THE STEM AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 7281748 ↗
• InjuryDec 19, 2017Appropriate Device Problem Term/Code Not Available

  PATIENT WAS COMPLAINING OF PAIN, TESTS WERE DONE TO DETERMINE THAT THE HIP HAD A STAPHYLOCCOCUS INFECTION. SURGEON DECIDED TO PERFORM STAGE ONE REVISION AND REMOVED ALL OF THE CURRENT IMPLANTS.

  Patient problems: Unspecified Infection

  MAUDE report 7129029 ↗
• InjuryNov 30, 2017Loose or Intermittent Connection

  REVISION DUE TO QUADRA-H ASEPTIC LOOSENING 11 YEARS AFTER PRIMARY. PATIENT HAD A FALL IN 2006 (PRIMARY SURGERY YEAR) AND THE SURGEON SUSPECTED IT MIGHT BE THE REASON FOR THE LOOSENING. THE SURGEON REVISED THE CERAMIC HEAD AND THE STEM SUCCESSFULLY.

  Patient problems: Fall

  MAUDE report 7070546 ↗

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