Quadra H femoral stems 01.12.032Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 07630030802140), received between Oct 30, 2018 and May 15, 2026 — classified as 23 injuries.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (8 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryMay 15, 2026Osseointegration Problem

  AT ABOUT 8 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN DUE TO A CONFIRMED LOOSE STEM AND THE CAUSE IS UNKNOWN. THERE WERE NO INDICATIONS OF TRAUMA. THE SURGEON REVISED THE MEDACTA STEM AND HEAD TO A COMPETITOR STEM AND HEAD AND REVISED THE MEDACTA FLAT PE HC LINER D 36/E TO A MEDACTA DOUBLE MOBILITY HC LINER D 28/DMC AND CONVERTER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening; Inadequate Osseointegration

  MAUDE report 25185337 ↗
• InjuryApr 30, 2024Fracture; Fracture

  THE PATIENT UNDERWENT PRIMARY SURGERY ON (B)(6) 2022. ON (B)(6) 2022, THE PATIENT HAS BEEN REVISED THE FIRST TIME BECAUSE OF SURGICAL WOUND ISSUES. CERAMIC BALL HEAD Ø36 SIZE XL AND LINER Ø36/E REVISED SUCCESSFULLY AND THE SURGEON IMPLANTED CERAMIC BALL HEAD (Ø36 SIZE XL) AND PE LINER. ON (B)(6) 2022, THE PATIENT UNDERWENT A SECOND REVISION SURGERY DUE TO JOINT LUXATION. BALL HEAD, LINER AND ACETABULAR SHELL HAVE BEEN SUCCESSFULLY REVISED AND VERSAFITCUP DM Ø58MM, LINER DM Ø28/58MM DMI AND COCR BALL HEAD Ø28 SIZE XL (+7) WERE IMPLANTED. SUBSEQUENTLY TO THIS, ON (B)(6) 2022, THE PATIENT HAS BEEN REVISED BECAUSE OF INFECTION AND THE SURGEON PERFORMED A WASHOUT WITH REVISION OF MOBILE PARTS OF THE PROSTHESIS. PRESENTLY, ON (B)(6) 2024, THE PATIENT HAS BEEN REVISED FOR THE FOURTH TIME BECAUSE OF STEM NECK BREAKAGE. NO TRAUMA EVENTS REPORTED. NO ISSUES DETECTED WITH THE OTHER IMPLANTS. ALL COMPONENTS HAVE BEEN REVISED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 19210983 ↗
• InjuryMar 21, 2024Osseointegration Problem; Osseointegration Problem

  AT ABOUT 5 YEARS 10 MONTHS AFTER THE PRIMARY, STEM WAS FOUND TO HAVE RADIOLUCENT LINES ON XRAY. REVISION SURGERY WAS PERFORMED. THE STEM HAD NO BONE ONGROWTH AND THE SURGEON WAS ABLE TO REMOVE IT BY PULLING IT OUT BY HAND. FEMORAL COMPONENTS SUCCESSFULLY REVISED WITH COMPETITOR'S COMPONENTS.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18949222 ↗
• InjuryJan 25, 2024Migration; Migration

  REVISION SURGERY FOR STEM LOOSENING AT ABOUT 8 YEARS AND 4 MONTHS FROM PRIMARY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18578851 ↗
• InjuryJul 21, 2022Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 7 YEARS AFTER THE PRIMARY, REVISION SURGERY WAS PERFORMED FOLLOWING ASEPTIC STEM LOOSENING. THE SURGEON REVISED SUCCESSFULLY STEM, INLAY AND HEAD.

  Patient problems: Inadequate Osseointegration

  MAUDE report 15072643 ↗
• InjuryJun 21, 2022Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED 7 YEARS AND 2 MONTH AFTER THE PRIMARY SURGERY DUE TO STEM LOOSENING. HEAD AND STEM REVISED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 14752267 ↗
• InjuryNov 9, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  REVISION SURGERY WAS PERFORMED DUE TO STEM LOOSENING 5 YEARS AFTER THE PRIMARY SURGERY. THE PATIENT IS VERY ACTIVE, HE PERFORMS A LOT OF RUNNING TRAILS.

  Patient problems: Insufficient Information

  MAUDE report 12779241 ↗
• InjuryOct 28, 2021Unintended Movement; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY WAS PERFORMED ABOUT 4 YEARS AFTER THE PRIMARY SURGERY DUE TO STEM MOBILIZATION. THE EXACT PRIMARY DATE IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 12711292 ↗
• InjuryMay 31, 2021Osseointegration Problem; Osseointegration Problem

  REVISION SURGERY PERFORMED DUE TO STEM MOBILIZATION 7 YEARS 10 MONTHS AFTER THE PRIMARY. STEM AND HEAD SUCCESSFULLY REVISED.

  Patient problems: Insufficient Information

  MAUDE report 11906934 ↗
• InjuryMar 12, 2021Loose or Intermittent Connection

  REVISION SURGERY PERFORMED 7 YEARS AND 2 MONTHS AFTER THE PRIMARY SURGERY DUE TO ASEPTIC LOOSENING OF THE STEM. THE STEM AND BALL HEAD WERE REVISED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11473643 ↗
• InjuryJan 28, 2021Break; Break

  REVISION SURGERY PERFORMED AFTER ABOUT 14 YEARS FROM THE PRIMARY SURGERY DUE TO FEMUR BONE FRACTURE AND THE BREAKAGE OF THE STEM NECK. THE PATIENT ALREADY HAD MANY INTERMEDIATE REVISION HIP SURGERIES NOT INVOLVING THE STEM. THE REMOVAL OF THE EXPLANTS PERFORMED ON DECEMBER 31ST, 2020 WAS DONE VIA POSTERIOR APPROACH BY A FEMORAL FLAP. THE ACETABULAR SHELL WAS IN GOOD CONDITION AND WAS LEFT IN PLACE. THE CERAMIC LINER WAS REMOVED AND REPLACED BY A PE HIGHCROSS INLAY, THE STEM WAS REPLACED BY A CEMENTLESS STEM AND THE FEMORAL HEAD WAS ALSO REPLACED.

  Patient problems: Bone Fracture(s)

  MAUDE report 11243438 ↗
• InjuryDec 21, 2020Loose or Intermittent Connection

  LOOSENING OF A QUADRA-H STEM IMPLANTED IN 2009. STEM, HEAD AND LINER HAVE BEEN SUCCESSFULLY REVISED (11 YEARS AND 10 MONTHS AFTER PRIMARY SURGERY). REVISION WAS DONE WITH A MINIMAX.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11045454 ↗
• InjurySep 29, 2020Loose or Intermittent Connection

  REVISION SURGERY PERFORMED AFTER 2 YEARS AND 3 MONTHS AFTER THE PRIMARY SURGERY DUE TO ASEPTIC LOOSENING OF THE STEM. THE STEM AND HEAD WERE REVISED.

  Patient problems: Failure of Implant

  MAUDE report 10600391 ↗
• InjuryApr 7, 2020Loosening of Implant Not Related to Bone-Ingrowth

  ASEPTIC LOOSENING OF A QUADRA 6 YEARS AND 4 MONTHS AFTER PRIMARY. PATIENT REPORTED A FALL IN 2019. QUADRA STEM REVISED SUCCESSFULLY WITH A BIGGER ONE.

  Patient problems: Joint Disorder

  MAUDE report 9932759 ↗
• InjuryJan 17, 2020Loose or Intermittent Connection

  REVISION SURGERY PERFORMED ALMOST 1 YEAR AND 2 MONTHS AFTER PRIMARY FOLLOWING STEM LOOSENING. STEM, HEAD AND LINER WERE REVISED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 9600143 ↗
• InjuryDec 11, 2019Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY PERFORMED 2 YEARS AND 9 MONTHS AFTER THE PRIMARY DUE TO ASEPTIC LOOSENING OF THE QUADR H STEM (THE PATIENT IS A HEAVY WORKING FARMER). THE SURGEON REVISED THE STEM AND THE HEAD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9450058 ↗
• InjuryDec 3, 2019Loosening of Implant Not Related to Bone-Ingrowth

  PATIENT REQUIRED REVISION DUE TO THIGH PAIN (STEM LOOSENING) ALMOST 5 YEARS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 9401757 ↗
• InjurySep 20, 2019Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY PERFORMED, 4 YEARS AND 8 MONTHS AFTER PRIMARY SURGERY, DUE TO PAIN CAUSED BY LOOSENING OF THE FEMORAL STEM. THE REVISION SURGERY WAS PERFORMED ANTERIORLY. THE QUADRA STEM WAS REMOVED USING THE EXPLANT INSTRUMENT AND OSTEOTOMES. THE STEM WAS BONDED AT THE TIP BUT THE SURGEON INFORMED TOLD THAT IT WAS LOOSE PROXIMALLY. THE SURGEON THEN BROACHED THE BONE WITH MINIMAX BROACHES AND IMPLANTED A SIZE 3 LEFT MINIMAX STEM, WITH A 32 M CERAMIC HEAD. BONE GRAFT WAS ALSO USED IN THE FEMORAL CANAL. ALSO THE HEAD WAS REVISED.

  Patient problems: Pain

  MAUDE report 9097884 ↗
• InjuryAug 12, 2019Appropriate Device Problem Term/Code Not Available

  THE PATIENT RETURNED WITH PAIN AND RADIOGRAPHIC EVIDENCE OF PROXIMAL LUCENCY, DISTAL TIP BONE INGROWTH ONLY. THE PATIENT WAS QUITE ACTIVE VERY EARLY ON FOLLOWING THE PRIMARY SURGERY AND THIS, ALONG WITH THE TIGHT DISTAL FEMORAL CANAL (DORR TYPE A) MAY HAVE CONTRIBUTED TO THE REASON FOR REVISION. SURGEON REVISED THE HIP, STEM AND HEAD WERE REMOVED ALMOST 5 YEARS AND 5 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON JULY 15 WE WERE INFORMED ABOUT THE REVISION SURGERY THAT WAS PERFORMED ON (B)(6).

  Patient problems: Inadequate Osseointegration

  MAUDE report 8883100 ↗
• InjuryApr 18, 2019Loose or Intermittent Connection

  ON (B)(6) WE WERE INFORMED ABOUT A REVISION SURGERY PLANNED ON (B)(6). ABOUT 5 YEARS AND 3 MONTHS AFTER PRIMARY THE SURGEON REVISED THE PATIENT FOR STEM SUBSIDENCE. STEM AND CERAMIC HEAD SWAPPED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 8527536 ↗
• InjuryApr 16, 2019Fracture; Device Dislodged or Dislocated

  THE PATIENT DEVELOPED A CALCAR FRACTURE 5 DAYS AFTER PRIMARY SURGERY, IT WAS NOT PICKED UP AT THE TIME OF INITIAL SURGERY. ON (B)(6) STEM HAD SUBSIDED AND ULTIMATELY DISLOCATED, THE SURGEON OPENED UP AND REMOVED THE STEM, HE CABLED CALCAR AND BROACHED 1 SIZE HIGHER.

  Patient problems: Bone Fracture(s)

  MAUDE report 8518692 ↗
• InjuryNov 21, 2018Loose or Intermittent Connection

  ABOUT 7 YEARS AND 8 MONTHS AFTER PRIMARY THE SURGEON REVISED THE PATIENT FOR STEM LOOSENING. THE SURGERY WAS COMPLETED SUCCESSFULLY. NEW IMPLANTS: QUADRA H LAT SIZE 4 AND MECTACER 32MM BALL HEAD MEDIUM.

  Patient problems: Joint Disorder

  MAUDE report 8095225 ↗
• InjuryOct 30, 2018Loose or Intermittent Connection

  ON (B)(6) 2018 WE WERE INFORMED THAT A REVISION SURGERY WILL BE PERFORMED DUE TO ASEPTIC FEMORAL LOOSENING, THE REASON IS PROBABLY PE WEAR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8019251 ↗

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