Quadra H femoral stems 01.12.035Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 07630030802171), received between Sep 7, 2017 and Sep 1, 2026 — classified as 13 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjurySep 1, 2026Osseointegration Problem

  Patient problems: Aseptic loosening; Inadequate Osseointegration

  MAUDE report 50543257 ↗
• InjuryFeb 24, 2023Migration; Migration

  ON (B)(6) 2022, THE PATIENT HAD A PRIMARY HIP SURGERY AFTER A FALL AND CONSEQUENT FEMORAL BONE FRACTURE. PRESENTLY, ON (B)(6) 2023, THE PATIENT CAME IN REPORTING A JOINT LUXATION. THE SURGEON NOTICED THAT THE STEM APPEARED TO BE UNDERSIZED AND HAD SIGNIFICANT SUBSIDENCE. THE SURGERY WAS COMPLETED SUCCESSFULLY REVISING THE MEDACTA STEM AND HEAD TO A COMPETITOR STEM AND HEAD, AND REVISING THE MEDACTA CUP AND LINER WITH A NEW MEDACTA CUP AND LINER.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16435302 ↗
• MalfunctionJun 24, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  DURING SURGERY A QUADRA-H SIZE 5 (REF. 01.12.035, LOT 152232B) WAS OPENED AND IN THE PACKAGE THERE WAS A QUADRA-S SIZE 5 (REF. 01.12.015, LOT 101086A). A BACK-UP QUADRA-H WAS USED TO COMPLETE THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14797399 ↗
• InjurySep 28, 2021Osseointegration Problem; Osseointegration Problem

  10 YEARS 4 MONTHS AFTER THE PRIMARY THE PATIENT CAME IN REPORTING PAIN DUE TO STEM LOOSENING. STEM, HEAD AND LINER SUCCESSFULLY REVISED.

  Patient problems: Pain

  MAUDE report 12539777 ↗
• InjuryOct 27, 2020Loose or Intermittent Connection

  REVISION SURGERY 6 YEARS AND 1 MONTH AFTER PRIMARY FOR FEMORAL STEM LOOSENING. STEM AND HEAD REVISED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 10741394 ↗
• InjuryAug 11, 2020Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  1 YEAR AND 10 MONTHS AFTER PRIMARY SURGERY, REVISION SURGERY FOR SUSPECTED LOOSENING OF THE STEM. STEM, HEAD AND LINER REVISED SUCCESSFULLY. THE STEM COME OUT EASILY, SO THE LOOSENING IS CONFIRMED.

  Patient problems: Bone Fracture(s)

  MAUDE report 10389665 ↗
• InjuryJul 23, 2020Break; Break

  IMPLANT NECK BREAKAGE, PRIMARY SURGERY PERFORMED ON (B)(6) 2016. REVISION SURGERY PERFORMED ON (B)(6) 2020 (3 YEARS AND 6 MONTHS AFTER PRIMARY). THE PATIENT HAD MULTIPLE REVISION SURGERIES DUE TO INFECTION, IN 2017 AND 2019. IN THOSE REVISIONS SURGERIES, THE HEAD AND THE LINER WERE REPLACED.

  Patient problems: Unspecified Infection

  MAUDE report 10313460 ↗
• InjuryJul 16, 2020Appropriate Device Problem Term/Code Not Available

  6 YEARS AND 6 MONTHS AFTER THE PRIMARY SURGERY THE SURGEON SAW OSTEOLYSIS AROUND THE STEM AND THE PATIENT HAD SOME PAIN. THE SURGEON DECIDES TO REMOVE THE IMPLANTS AND TAKES THE LIQUID FOR ANALYSIS TO CONFIRM IF THERE WAS AN INFECTION(RESULTS OF THE TEST NOT AVAILABLE).

  Patient problems: Osteolysis

  MAUDE report 10282569 ↗
• InjuryApr 17, 2019Loose or Intermittent Connection

  ON MARCH 18 WE WERE INFORMED ABOUT A REVISION SURGERY PLANNED ON MARCH 19. REVISION PERFORMED 4 YEARS AND 3 MONTHS FROM THE PRIMARY DUE TO LEFT SIDE STEM LOOSENING. THE REASON OF THE MOBILIZATION IS UNKNOWN. THE REVISION SURGERY COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 8522865 ↗
• InjuryOct 19, 2018Appropriate Device Problem Term/Code Not Available

  ABOUT 1 YEAR AND 5 MONTHS AFTER PRIMARY THE SURGEON REVISED THE PATIENT FOR STEM MOBILIZATION. THE SURGEON REVISED THE STEM SUCCESSFULLY.

  Patient problems: No Information

  MAUDE report 7984648 ↗
• InjurySep 20, 2018Loose or Intermittent Connection

  ABOUT 3 YEARS AND 9 MONTHS AFTER PRIMARY THE SURGEON REVISED THE PATIENT FOR STEM LOOSENING. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 7893358 ↗
• InjurySep 19, 2018Loose or Intermittent Connection

  ON AUG 20, 2018 WE WERE INFORMED THAT THE PATIENT NEEDED A REVISION SURGERY DUE TO LOOSENING OF FEMUR PROSTHESIS DETECTED THROUGH BONE SCAN 5 YEARS AND 5 MONTHS AFTER PRIMARY; RADIOLUCENT LINES WERE FOUND AROUND THE DISTAL PORTION OF THE STEM. PATIENT HAD PAIN. ON (B)(6) 2018 THE SURGEON REVISED THE MPACT FLAT PE HC LINER 36/F (01.32.3648HCT), QUADRA LAT S5 STEM (01.12.035) AND 36M CERAMIC HEAD (38.49.7179.285.00) WITH ZIMMER REVISION STEM AND HEAD. THE SURGEON CHANGED THE LINER TO HAVE A TOTAL NEW BEARING SURFACE AND ARTICULATION. CASE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 7888914 ↗
• InjuryJun 21, 2018Loose or Intermittent Connection

  THE PATIENT CAME IN COMPLAINING OF PAIN 8 YEARS AND 4 MONTHS AFTER PRIMARY. INTRAOPERATIVELY THE SURGEON DETERMINED THAT THE STEM WAS LOOSE. THE SURGEON REVISED THE MEDACTA STEM, ALONG WITH THE OTHER COMPANY'S CUP, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 7624916 ↗
• InjurySep 7, 2017Device Slipped

  THE PATIENT COMPLAINED OF PAIN. THE SURGEON SUSPECTED IT WAS LOOSE. INTRA-OPERATIVELY IT WAS CONCLUDED THE STEM WAS LOOSE AND IT WAS REMOVED AND REPLACED.

  Patient problems: Joint Disorder; Pain

  MAUDE report 6847620 ↗

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