Quadra H femoral stems 01.12.20SNRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 07630030802607), received between Oct 13, 2017 and Apr 9, 2026 — classified as 13 injuries.

The most frequently reported specific device problem is “Fracture” (3 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryApr 9, 2026Osseointegration Problem

  REVISION SURGERY PERFORMED ABOUT 8 YEARS AND 10 MONTHS AFTER THE PRIMARY SURGERY DUE TO STEM ASEPTIC LOOSENING. NO INFECTION IDENTIFIED AND NO TRAUMA REPORTED.

  Patient problems: Aseptic loosening

  MAUDE report 24826105 ↗
• InjuryOct 26, 2023Failure to Osseointegrate; Failure to Osseointegrate

  AT ABOUT 3 YEARS AND 2 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED SUCCESSFULLY THE MEDACTA HEAD AND STEM WITH COMPETITOR COMPONENTS AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER.

  Patient problems: Implant Pain; Inadequate Osseointegration

  MAUDE report 18011654 ↗
• InjuryMar 19, 2022Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  THE SURGEON REVISED THE QUADRA-H STEM AND THE CERAMIC HEAD FOLLOWING STEM LOOSENING 4 YEARS AND 9 MONTHS AFTER PRIMARY. A NEW CERAMIC HEAD AND A CEMENTED XACTA STEM WERE IMPLANTED.

  Patient problems: Insufficient Information

  MAUDE report 13826450 ↗
• InjuryOct 19, 2020Fracture; Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

  PRIMARY SURGERY PERFORMED SUCCESSFULLY IN THE MORNING. IN THE AFTERNOON THE SURGEON NOTICED THAT THE PATIENT WAS IN PAIN AND LEGG WAS SHORTER THAN THE OTHER SUDDENLY. HE TOOK A CT WHERE THE STEM WAS SUBSIDED AND IT SHOWED A PERI PROSTHETIC FRACTURE, SUBSIDENCE HAPPENED AFTER CAUSING THE FRACTURE. PATIENT HAS A VERY OSTEOPOROTIC BONE QUALITY. REVISION SURGERY PERFORMED 7 DAYS AFTER PRIMARY.

  Patient problems: Bone Fracture(s)

  MAUDE report 10697594 ↗
• InjuryJul 24, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT HAD A TOTAL HIP REPLACEMENT ON THE (B)(6) 2019. 3 MONTHS AFTER PRIMARY THE PATIENT WAS OPERATED FOR CALCAR FRACTURE AND STEM SUBSIDENDE. THE SURGEON ONLY FIXED THE FRACTURE WITH CERCLAGE. 11 MONTHS AFTER PRIMARY SURGERY THE PATIENT WAS OPERATED AGAIN FOR PAIN (THE REASON OF PAIN IS UNKNOWN), THE SURGEON REVISED SUCCESSFULLY THE CERAMIC HEAD AND STEM.

  Patient problems: Pain

  MAUDE report 10319328 ↗
• InjuryDec 23, 2019Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY PERFORMED 3 YEARS AND 1 MONTH AFTER THE PRIMARY DUE TO INSTABILITY CAUSED BY A LOOSE STEM. THE CAUSE OF THE LOOSE STEM IS UNKNOWN. THE SURGEON REVISED THE STEM, HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 9510765 ↗
• InjuryAug 12, 2019Appropriate Device Problem Term/Code Not Available

  ABOUT 3 MONTHS AND A HALF AFTER PRIMARY THE SURGEON REVISED THE PATIENT HIP FOR AN INFECTION. THE PATHOGEN IS UNKNOWN. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 8883102 ↗
• InjuryJul 19, 2019Loose or Intermittent Connection

  ON (B)(6) 2019 WE WERE INFORMED OF A REVISION SURGERY, THAT WAS THEN PERFORMED ON (B)(6) 2019, AFTER 1 YEAR AND 9 MONTHS FROM THE PRIMARY, DUE TO STEM LOOSENING. THE SURGEON REMOVED THE STEM AND FEMORAL HEAD AND REPLACED THEM.

  Patient problems: Inadequate Osseointegration

  MAUDE report 8806055 ↗
• InjuryJan 10, 2019Appropriate Device Problem Term/Code Not Available

  ABOUT 24 DAYS AFTER SURGERY FOR A BONE FRACTURE DUE TO UNDERSIZED STEM, THE SURGEON REVISED THE PATIENT JOINT SWAPPING SUCCESSFULLY THE STEM AND THE HEAD.

  Patient problems: Bone Fracture(s)

  MAUDE report 8235434 ↗
• InjurySep 21, 2018Fracture

  THE PATIENT CAME IN COMPLAINING OF PAIN FEW DAYS AFTER PRIMARY SURGERY. THE SURGEON DETERMINED THAT THE PATIENT HAD FRACTURED THE FEMUR. THE CAUSE OF THE FRACTURE IS UNKNOWN. NO TRAUMA WAS REPORTED. THE SURGEON SUCCESSFULLY REVISED THE STEM, HEAD AND LINER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7897537 ↗
• InjuryAug 31, 2018Fracture

  THE SURGEON USED ANTERIOR OFF TABLE APPROACH. THE SURGEON REMOVED THE QUADRA STEM ALONG WITH THE CERAMIC HEAD DUE TO FEMUR FRACTURE OCCURRED 2 WEEKS AFTER PRIMARY. THE STEM WAS REMOVED EASILY. THE FRACTURE WAS CABLED AND THE SURGEON CEMENTED IN A SIZE 0, 44 OFFSET XACTA STEM WITH A 36 -4 CERAMIC HEAD.

  Patient problems: Bone Fracture(s)

  MAUDE report 7837107 ↗
• InjuryApr 11, 2018Device Slipped

  ABOUT 2 YEARS AND 2 MONTHS AFTER PRIMARY THE SURGEON REVISED THE PATIENT FOR STEM LOOSENING. STEM SWAPPED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 7421485 ↗
• InjuryOct 13, 2017Loose or Intermittent Connection

  THE PATIENT HAD BEEN COMPLAINING OF PAIN. THE REQUESTED THE PATIENT GET AN X-RAY AND DETERMINED THE IMPLANT MUST BE LOOSE. REVISION SURGERY WAS PERFORMED AND THE STEM WAS REMOVED AS IT WAS IN FACT LOOSE.

  Patient problems: Joint Disorder; Pain

  MAUDE report 6947954 ↗

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