Quadra H femoral stems 01.12.021Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 07630030802027), received between Aug 3, 2017 and Dec 18, 2025 — classified as 26 injuries.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (9 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 26 reports, in the reporter's own words as published by the FDA.

• InjuryDec 18, 2025Malposition of Device; Naturally Worn; Osseointegration Problem; Malposition of Device; Naturally Worn; Osseointegration Problem

  AT ABOUT 12 YEARS 1 MONTH FROM THE PRIMARY, REVISION SURGERY, LEFT SIDE, WAS PERFORMED DUE TO DIFFERENT FACTORS: IT WAS REPORTED STEM LOOSENING, ILIOPSOAS IMPINGEMENT, ANTERIOR OVERHANG OF THE ACETABULAR CUPAND POSSIBLE POLYETHYLENE INSERT WEAR.

  Patient problems: Aseptic loosening; Inadequate Osseointegration; Joint Laxity

  MAUDE report 23837282 ↗
• InjuryNov 10, 2025Osseointegration Problem; Osseointegration Problem

  AT ABOUT 17 YEARS AND 9 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TOA THIGH PAIN FOR A STEMQUADRA-H CEMENTLESSLOOSENING.DR HOCKINGS PERFORMED THIS REVISION THROUGH THE ANTERIOR APPROACH WITH NO DIFFICULTIES ANDREPLACED THE STEM WITH ANAMIS CCEMENTED STEM AND THE HEAD WITH A CERAMIC 36 M.

  Patient problems: Aseptic loosening; Inadequate Osseointegration

  MAUDE report 23510671 ↗
• InjuryJan 8, 2025Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT HAD THIGH PAIN AND THE STEM WAS SHOWING SIGNS OF LOOSENING DISTALLY IN THE FEMUR BONE. AT 4 YEARS AND 11 MONTHS POST PRIMARY THE SURGEON DECIDED TO REVISE THE STEM AND CONFIRMED THAT WAS LOOSE DISTALLY.

  Patient problems: Pain

  MAUDE report 21100362 ↗
• InjuryFeb 17, 2023Failure to Osseointegrate; Failure to Osseointegrate

  REVISION AT ABOUT 14 YEARS AND 2 MONTHS POST PRIMARY FOR STEM AND CUP LOOSENING. THE SURGEON REVISED ALL THE IMPLANT SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 16396224 ↗
• InjuryDec 9, 2022Osseointegration Problem; Osseointegration Problem

  REVISION SURGERY PERFORMED AT ABOUT 11 YEARS 2 MONTHS FROM THE PRIMARY DUE TO LOOSENING OF THE STEM. THE SURGERY WAS COMPLETED SUCCESSFULLY BY IMPLANTING A MINIMAX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15950502 ↗
• InjuryOct 27, 2022Osseointegration Problem; Osseointegration Problem

  REVISION SURGERY PERFORMED AT ABOUT 6 YEARS AND 1 MONTH FROM PRIMARY FOR STEM LOOSENING. STEM HEAD AND LINER REVISED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 15679266 ↗
• InjuryMay 6, 2022Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY FOLLOWING STEM LOOSENING 6 YEARS AND 5 MONTHS AFTER PRIMARY. THE STEM, LINER, AND HEAD WERE REVISED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 14303478 ↗
• InjuryApr 29, 2022Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY FOLLOWING STEM LOOSENING, NO INFECTION HAS BEEN DETECTED. THE DEVICE WAS IMPLANTED IN 2013, THE EXACT PRIMARY SURGERY DATE IS UNKNOWN.

  Patient problems: Inadequate Osseointegration

  MAUDE report 14250187 ↗
• InjuryFeb 10, 2022Osseointegration Problem; Osseointegration Problem

  AT 2 YEARS AFTER THE PRIMARY, REVISION SURGERY WAS PERFORMED FOLLOWING THE ASEPTIC LOOSENING OF THE STEM.

  Patient problems: Insufficient Information

  MAUDE report 13504581 ↗
• InjuryJan 21, 2022Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY FOLLOWING ASEPTIC LOOSENING OF THE STEM. THE PRIMARY SURGERY YEAR IS 2010.

  Patient problems: Inadequate Osseointegration

  MAUDE report 13314976 ↗
• InjuryJun 4, 2021Appropriate Device Problem Term/Code Not Available; Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY WAS PERFORMED 4 YEARS AND 8 MONTHS AFTER PRIMARY FOR STEM LOOSENING. ALL IMPLANTS WERE REVISED SUCCESSFULLY. THE ACETABULAR COMPONENTS SWAP WAS A SURGEON CHOICE, THERE WERE NO ACETABULAR PROBLEMS, BUT THE SURGEON REVISED THEM TO REDUCE THE RISK OF POTENTIAL INFECTION DUE TO THE SURGERY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11938602 ↗
• InjuryMay 17, 2021Unintended Movement; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED DUE TO STEM MOBILIZATION 9 YEARS AND 5 MONTHS AFTER THE PRIMARY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11831977 ↗
• InjuryMay 6, 2021Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED DUE TO STEM LOOSENING 12 YEARS 10 MONTHS AFTER THE PRIMARY. STEM, HEAD, AND LINER SUCCESSFULLY REVISED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11784064 ↗
• InjuryApr 22, 2021Loose or Intermittent Connection

  FOLLOWING STEM LOOSENING STEM AND INLAY WILL BE REVISED, THE CUP WILL BE LEFT IN PLACE. REVISION SURGERY WAS PLANNED FOR THE (B)(6) 2021 BUT IT WAS POSTPONED DUE TO CORONAVIRUS. PRIMARY DATE IS UNKNOWN.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11705226 ↗
• InjuryMar 12, 2021Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED DUE TO ASEPTIC STEM LOOSENING 2 YEARS 11 MONTHS AFTER THE PRIMARY. THE SURGEON REVISED THE STEM, HEAD AND LINER.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11473933 ↗
• InjuryFeb 25, 2021Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  REVISION DUE TO ASEPTIC STEM LOOSENING 1 YEAR AND 7 MONTHS AFTER PRIMARY. IT IS POSSIBLE THAT ALSO THE HEAD WAS REVISED EVEN IF IT WAS NOT REPORTED IN THE COMPETENT AUTHORITY REPORT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11377460 ↗
• InjuryDec 20, 2020Fracture; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS OPERATED 15 DAYS AFTER PRIMARY DUE TO A PERIPROSTEHTICAL FRACTURE WHICH EXTENDED FROM THE CALCAR DOWN TO THE MINOR TROCHANTER. THE SURGEON DOESN'T KNOW IF THE FRACTURE WAS DONE DURING THE PRIMARY SURGERY ON (B)(6) 2020 OR IF IT IS DUE THE FACT THAT THE PATIENT FELL. THE WAS EXCHANGED WITH A NEW QUADRA STEM SIZE 3 AND THE BONE GOT A CERCLAGE, CERAMIC HEAD WAS REVISED AS WELL.

  Patient problems: Hip Fracture

  MAUDE report 11043167 ↗
• InjuryDec 18, 2020Loss of Osseointegration; Loss of Osseointegration

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

  Patient problems: Insufficient Information

  MAUDE report 11036669 ↗
• InjuryDec 9, 2020Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY DUE TO PAIN AND STEM LOOSENING AFTER 5 YEARS FROM THE PRIMARY SURGERY. THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2014 AND THE ISSUE WAS DISCOVERED DURING A CLINICAL VISIT FOLLOW-UP ON THE (B)(6) 2019.

  Patient problems: Pain

  MAUDE report 10976726 ↗
• InjuryDec 7, 2020Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE OF THE PAIN IS UNKNOWN. THE SURGEON REVISED THE STEM AND HEAD WITH A COMPETITOR STEM AND HEAD ALMOST 8 YEARS AND 1 MONTH AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY. PATIENT'S LEFT HIP WAS REVISED. THE PATIENT PREVIOUSLY CAME IN AND HAD THE RIGHT HIP REVISED WITH THE EXACT SAME ISSUE.

  Patient problems: Pain

  MAUDE report 10959340 ↗
• InjuryApr 17, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY PERFORMED, 11 MONTHS AFTER PRIMARY SURGERY, DUE TO STEM LOOSENING. AS PER THE POSTOPERATORY XRAYS OF THE PRIMARY SURGERY THE PATIENT HAD A FRACTURE OF THE GREATER TROCHANTER OF THE RIGHT FEMUR, FOR THAT REASON THE SURGEON USED A CERCLAGE WITH WIRE. AND MAYBE, THIS FRACTURE WOULD BE A REASON OF THE LOOSENING OF THE STEM. ABOUT THE REVISION SURGERY: INTRAOPERATIVELY, THE QUADRA H STEM STD SIZE 1 WAS WITHDRAWN, THE STEM WAS TOTALLY LOOSENED AND WITHOUT HYDROXYAPATITE, THE FRACTURE OF THE GREATER TROCHANTER WAS CONSOLIDATED, THE CERCLAGE WAS WITHDRAWN, THE FEMORAL CANAL WAS WASHED THOROUGHLY, A REVISION STEM OF ANOTHER COMPANY WAS IMPLANTED AND THE MEDACTA FEMORAL HEAD WAS CHANGED FROM A COCR 32 XL +7 BY A COCR 32 L +3.5.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9971095 ↗
• InjuryDec 23, 2019Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY PERFORMED ALMOST 5 YEARS AND 11 MONTHS AFTER PRIMARY FOLLOWING PAIN DUE TO AN ASEPTIC LOOSENING OF THE STEM. DURING THE REVISION, THEY CHANGED THE STEM, THE HEAD AND THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 9510757 ↗
• InjuryNov 27, 2018Loose or Intermittent Connection

  REVISION SURGERY DUE TO STEM LOOSENING 10 MONTHS AFTER THE PRIMARY SURGERY.

  Patient problems: Joint Disorder

  MAUDE report 8105807 ↗
• InjuryNov 13, 2018Loose or Intermittent Connection

  ON (B)(6) 2018 WE WERE INFORMED BY THE SURGEON THAT THE PATIENT FEMORAL STEM WAS LOOSE 6 YEARS AFTER PRIMARY; A REVISION SURGERY WAS BOOKED FOR (B)(6) 2018 TO REMOVE THE STEM AND REPLACE IT WITH A SYNERGY STEM AND A CERAMIC HEAD FROM SMITH AND NEPHEW.

  Patient problems: Joint Disorder

  MAUDE report 8064122 ↗
• InjuryJun 20, 2018Appropriate Device Problem Term/Code Not Available

  REVISION OF THE RIGHT STEM 2 YEARS AND 9 MONTHS AFTER PRIMARY. THE PRIMARY STEM HAD GOOD DISTAL FIXATION, HOWEVER HAD MOVED PROXIMALLY. THE CORTICAL BONE IN THE METAPHYSIS WAS THICKER THAN USUAL.

  Patient problems: No Information

  MAUDE report 7619809 ↗

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