Quadra H femoral stems 01.12.034Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07630030802164), received between Sep 13, 2017 and Jun 17, 2026 — classified as 10 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJun 17, 2026Osseointegration Problem

  REVISION SURGERY DUE TO STEM LOOSENING AFTER ABOUT 7 YEARS AND 7 MONTHS FROM PRIMARY. STEM, HEAD AND LINER REVISED.

  Patient problems: Aseptic loosening

  MAUDE report 25528750 ↗
• MalfunctionOct 24, 2024Break; Break

  ON THE (B)(6) 2023, THE PATIENT UNDERWENT A PRIMARY HIP SURGERY ON THE RIGHT SIDE DUE TO COXARTHROSIS. SURGERY WAS COMPLETED SUCCESSFULLY WITH SATISFACTORY FIT AND POSITION OF THE IMPLANTS AS WELL AS PRIMARY STABILITY WITH THE CUP AND THE STEM. DURING THE PATIENT MOBILIZATION IN THE SECOND POSTOPERATIVE WEEK, INCREASING PAIN ESPECIALLY IN STRESS CONDITIONS WAS DETECTED AND GRADUALLY THE PAIN BECAME CHRONIC. FIRST X-RAYS TAKEN DURING A FOLLOW UP DID NOT SHOW SIGNS OF FRACTURE OR OTHER ISSUES. THE FOLLOWING CT SCAN SHOWED A VANCOUVER B1 SPIRAL FRACTURE THAT HAD ALREADY REPAIRED AND IT WAS NOTICED SUBSIDENCE OF THE STEM. ON THE (B)(6) 2023, THE PATIENT HAS BEEN REVISED. A CERCLAGE (CCG BAND) WAS PLACED IN THE AREA OF THE FRACTURE, NEAR TO THE DISTAL PART OF THE STEM. NO MOBILIZATION OF THE STEM WAS DETECTED AND THE IMPLANT WAS ROTATIONAL STABLE, EVEN IF SUBSIDENCE OCCURRED. THE CERCLAGE WAS PLACED FOR SAFETY REASONS AND SURGEONS DECIDED TO LEAVE THE STEM AS IT WAS IN ORDER TO PREVENT ANY FURTHER FRACTURES. DUE TO THE OFFSET AND LEG LENGTH, SURGEONS DECIDED TO CHANGE THE INITIAL USED MEDACTA L CERAMIC HEAD 28MM TO A XXL MERETE HEAD WITH SLEEVE. SURGERY WAS COMPLETED SUCCESSFULLY. ON TH

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

  MAUDE report 20522030 ↗
• InjuryJun 12, 2023Failure to Osseointegrate; Failure to Osseointegrate

  AT ABOUT 7 YEARS 5 MONTHS AFTER THE PRIMARY, REVISION SURGERY PERFORMED DUE TO ASEPTING STEM LOOSENING. THE SURGEON REVISED SUCCESSFULLY STEM, HEAD AND LINER.

  Patient problems: Inadequate Osseointegration

  MAUDE report 17105639 ↗
• InjuryAug 3, 2022Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  ABOUT 5 YEARS AND 1 MONTH AFTER PRIMARY SURGERY, HEAD AND STEM WERE REVISED DUE TO STEM LOOSENING. SIGNS OF IMPINGEMENT ARE VISIBLE IN THE EXPLANTED STEM.

  Patient problems: Inadequate Osseointegration

  MAUDE report 15154906 ↗
• InjuryDec 22, 2020Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED ON THE (B)(6) 2020, 4 AND A HALF YEAR AFTER PRIMARY, DUE TO STEM LOOSENING. EXACT PRIMARY SURGERY DATE IS UNKNOWN.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11053943 ↗
• InjuryNov 11, 2020Failure to Osseointegrate

  INSUFFICIENT OSTEOINTEGRATION OF THE STEM. THE SURGEON REVISED SUCCESSFULLY THE STEM 3 YEARS AND 11 MONTHS AFTER PRIMARY SURGERY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 10821843 ↗
• InjuryJun 5, 2019Material Fragmentation; Loose or Intermittent Connection; Naturally Worn

  REVISION SURGERY AFTER ABOUT 10 YEARS AFTER PRIMARY SURGERY DUE TO ACETABULUM OSTEOLYSIS, SUSPECTED PE WEAR, METALLOSIS AND STEM LOOSENING. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 8670151 ↗
• InjuryMar 14, 2019Loose or Intermittent Connection

  THE PATIENT HAD STARTED TO COMPLAIN ABOUT HIP PAIN ON (B)(6) 2017, 4 YEARS AFTER PRIMARY. THE X-RAY HAD SHOWED A SHAFT LOOSENING. SINCE THE SYMPTOMS WERE NOT THAT STRONG YET AND THERE WERE MUSCULAR PROBLEMS, THEY INITIALLY AGREED ON A PHYSIOTHERAPY WITH THE INSTRUCTION THAT IF THE PAIN INTENSIFIED A STEM CHANGE WOULD HAVE TO BE MADE. 1 YEAR AND 8 MONTHS LATER, THAT MEANS 5 YEARS AND 8 MONTHS AFTER THE PRIMARY CASE, THE PATIENT WAS REVISED, WITH EXCLUSION OF INFECTION. THE SURGERY WAS COMPLETED SUCCESSFULLY REPLACING THE STEM.

  Patient problems: Inadequate Osseointegration

  MAUDE report 8421077 ↗
• InjuryNov 27, 2018Loose or Intermittent Connection

  REVISION SURGERY PERFORMED DUE TO STEM LOOSENING (LEFT SIDE) CAUSING PROXIMAL FEMORAL PAIN AFTER ABOUT 7 YEARS.

  Patient problems: Joint Disorder

  MAUDE report 8105809 ↗
• InjuryApr 19, 2018Device Slipped

  REVISION DUE TO PAIN ON THE FEMUR ABOUT 8 YEARS AFTER PRIMARY. THE STEM WAS LOOSE.

  Patient problems: Joint Disorder

  MAUDE report 7442814 ↗
• InjurySep 13, 2017Loose or Intermittent Connection

  THE PATIENT COMPLAINED OF ONGOING PAIN. THE SURGEON REVIEWED X-RAYS AND SUSPECTED LOOSENING OF THE STEM. REVISION SURGERY WAS UNDERTAKEN AND LOOSE STEM CONFIRMED INTRA-OPERATIVELY. IT WAS REMOVED AND REPLACED.

  Patient problems: Joint Disorder; Pain

  MAUDE report 6860916 ↗

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