Quadra H femoral stems 01.12.23SNRecalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 07630030802638), received between Dec 27, 2017 and Sep 19, 2025 — classified as 20 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (5 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjurySep 19, 2025Osseointegration Problem; Osseointegration Problem

  AT ABOUT 5 YEARS 7 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO HIP PAIN DUE TO A LOOSE STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE MEDACTA STEM AND HEAD WITH COMPETITOR COMPONENTS AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening

  MAUDE report 23093857 ↗
• InjurySep 9, 2024Osseointegration Problem; Osseointegration Problem

  REVISION SURGERY AT ABOUT 2 YEARS AND 2 MONTHS POST PRIMARY DUE TO QUADRA H STEM LOOSENING. THE PATIENT WAS STABLE HOWEVER WAS EXPERIENCING THIGH AND GROIN PAIN ON WEIGHT BEARING. THE STEM AND HEAD WERE REVISED AND A COMPETITOR STEM WAS SUCCESSFULLY IMPLANTED. NO ISSUES ON THE HEAD DETECTED.

  Patient problems: Implant Pain

  MAUDE report 20167737 ↗
• InjuryJul 16, 2024Osseointegration Problem; Osseointegration Problem

  AT ABOUT 7 YEARS 10 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE OF THE LOOSE STEM IS UNKNOWN. THE SURGEON REVISED THE MEDACTA STEM AND HEAD WITH COMPETITOR COMPONENTS AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 19749800 ↗
• InjuryJun 26, 2024Osseointegration Problem; Osseointegration Problem

  AT ABOUT 6 YEARS AND 10 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED SUCCESSFULLY THE STEM, HEAD AND LINER.

  Patient problems: Implant Pain

  MAUDE report 19611997 ↗
• InjuryMar 21, 2024Failure to Osseointegrate; Failure to Osseointegrate

  REVISION SURGERY WAS PERFORMED ABOUT 12 YEARS AND 2 MONTHS AFTER THE PRIMARY SURGERY DUE TO STEM LOOSENING. A FEMORAL FRACTURE WAS ALSO NOTED BUT IT IS UNKNOWN WHEN AND HOW IT HAPPENED. FRACTURE FIXED AND ALL IMPLANTS REVISED TO COMPETITOR SYSTEM.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18951623 ↗
• InjuryJan 10, 2024Osseointegration Problem; Osseointegration Problem

  AT ABOUT 7 YEARS AND 4 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A POTTED STEM. THE SURGEON REVISED THE STEM, HEAD AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 18484164 ↗
• InjuryFeb 1, 2023Migration; Migration

  AT ABOUT 2 YEARS 8 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A SUBSIDED STEM, AND THE CAUSE OF THE SUBSIDED STEM IS UNKNOWN. THE SURGEON REVISED THE HEAD, STEM, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 16276063 ↗
• InjuryDec 23, 2021Loose or Intermittent Connection

  AT 1 YEAR AND 7 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE OF THE LOOSE STEM IS UNKNOWN. THE SURGEON REVISED THE MEDACTA STEM AND HEAD WITH COMPETITOR COMPONENTS AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 13078036 ↗
• InjuryApr 14, 2021Failure to Osseointegrate

  FROM X-RAYS IT WAS RECOGNISED INSUFFICIENT OSSEOINTEGRATION OF THE STEM IN THE DISTAL PART, THE PATIENT HAD PAIN. THE SURGEON DECIDED TO REVISE THE PATIENT 1 YEAR 2 MONTHS AFTER THE PRIMARY. DURING THE SURGERY IT WAS HARD TO REMOVE THE STEM.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11663062 ↗
• InjuryFeb 4, 2021Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED DUE TO STEM SUBSIDENCE 3 YEARS AND 2 MONTHS AFTER THE PRIMARY SURGERY. THE SURGEON REVISED THE QUADRA H SN STANDARD SIZE 3 WITH A MINIMAX STEM - SIZE 6 AND THE HEAD WITH THE SAME SIZE IMPLANT.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11279338 ↗
• InjuryAug 11, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE OF THE PAIN IS UNKNOWN. THE SURGEON REVISED THE BIPOLAR HIP COMPONENTS TO TOTAL HIP COMPONENTS 3 YEARS AND 8 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 10389669 ↗
• InjuryJun 16, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING PAIN DUE TO A POTTED STEM. THE SURGEON REVISED THE STEM AND HEAD WITH ANOTHER COMPANY'S PRODUCT AND REVISED THE LINER WITH A MEDACTA LINER 8 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 10157887 ↗
• InjuryFeb 21, 2020Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY ABOUT 20 DAYS AFTER PRIMARY FOR STEM SUBSIDENCE. THE REASON IS UNKNOWN. FRACTURE AT LESSER TROCHANTER REGION DETECTED DURING REVISION. THE SURGEON REVISED SUCCESSFULLY THE STEM AND THE CERAMIC BALL HEAD.

  Patient problems: Hip Fracture

  MAUDE report 9738044 ↗
• InjuryAug 30, 2019Appropriate Device Problem Term/Code Not Available

  THE PATIENT RETURNED, 7 YEARS AFTER PRIMARY SURGERY, WITH PAIN OVER THE HIP AND ALSO DISSATISFACTION WITH LEG LENGTH SLIGHT DISCREPANCY. THE SURGEON BELIEVED THE PAIN WAS DUE TO HAVING HAD A LUMBAR FUSION FOLLOWING THE PRIMARY HIP REPLACEMENT AND THIS HAD CAUSED ANTERIOR TILT ON THE PELVIS. ON REVISION IT WAS VISIBLE THAT THE FEMORAL NECK WAS IMPINGING ON THE CUP DURING FLEXION AND SOME METALLOSIS WAS PRESENT. THE SURGEON TOOK SWABS FOR INVESTIGATION OF INFECTION, THEN PROCEEDED TO EXPLANT THE SCREW, CUP, LINER, HEAD (ANTERIOR APPROACH), REAM DEEPER TO A 54 REAMER AGAIN, AND REPLACE WITH A SIZE 56 MPACT CUP WITH TWO SCREWS. THE REVISION HAS BEEN PERFORMED FOR MULTIPLE REASONS: METALLOSIS, IMPINGEMENT, LEG LENGTH DISCREPANCY. NO INFECTION DETECTED.

  Patient problems: Joint Disorder

  MAUDE report 8949451 ↗
• InjuryJul 5, 2019Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED, 1 YEAR AND 8 MONTHS AFTER PRIMARY SURGERY, DUE TO INFECTION. THE PATHOGEN IS STAPHYLOCOQUE EPIDERMIS . IMPLANT WAS REMOVED AND A SPACER WAS IMPLANTED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 8764350 ↗
• InjuryJan 4, 2019Adverse Event Without Identified Device or Use Problem

  ONE WEEK AFTER PRIMARY FOR AN INFECTION CASE THE SURGEON PERFORMED AN I&D AND REVISED SUCCESSFULLY THE STEM, THE HEAD AND THE LINER. THE PATHOGEN WAS IDENTIFIED AS STREPTOCOCCUS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 8217200 ↗
• InjurySep 21, 2018Fracture

  ON (B)(6) 2018 THE AGENT WAS IN THEATRE WITH THE SURGEON WHO INFORMED HIM THAT THE PATIENT WAS FOUND TO HAVE A GT FRACTURE IMMEDIATELY AFTER PRIMARY CASE. THE INTRA-OP X-RAY TAKEN DURING PRIMARY DIDN'T SHOW ANY EVIDENCE OF FRACTURE WITH TRIAL IMPLANTS IN PLACE. HOWEVER THE POST OP XRAY IN RECOVERY SHOWED A POSSIBLE GT FRACTURE. THE PATIENT WAS SENT OFF FOR CT SCAN AND IT WAS CONFIRMED THERE WAS FEMUR, GT AND PELVIC FRACTURE. A MEDACTA REP ATTENDED THE PRIMARY CASE AND SAID THERE WAS NOTHING UNTOWARD DURING THE PROCEDURE, PATIENT WAS NOT OVERWEIGHT AND THERE WAS NO MENTION OF FRACTURE DURING THE PROCEDURE OR UNDERLYING EXTENSIVE DISEASE BONE DISEASE. THE SURGEON STATED THAT THE PATIENT HAD AVN. THE PATIENT WAS REOPERATED ON (B)(6) 2018: NO MEDACTA IMPLANT WAS REVISED, BUT ONLY CABLES WERE APPLIED.

  Patient problems: Joint Disorder

  MAUDE report 7897542 ↗
• InjuryAug 17, 2018Device Dislodged or Dislocated

  PATIENT PRESENTED WITH THIGH PAIN A FEW WEEKS POST PROCEDURE, RETURNING TO HOSPITAL POST THR WHERE A FRACTURE WAS NOTED. AFTER THAT, 1 MONTH AND HALF AFTER THE PRIMARY SURGERY, THE PATIENT FELL OUT OF BED AND DISPLACED THE PRE-EXISTING FRACTURE. ALL IMPLANTS WERE ABLE TO REMAIN IN PLACE, WITH CABLES & PLATES TO RELOCATE FRACTURE.

  Patient problems: Bone Fracture(s)

  MAUDE report 7793262 ↗
• InjuryJan 10, 2018Loose or Intermittent Connection; Difficult to Remove

  THE PATIENT EXPERIENCED PAIN AFTER GOING FOR A LONG BUSH WALK. THE STEM HAD SUBSIDED. THE PROXIMAL END OF THE STEM WAS NOT INGROWN SO THE STEM MAY HAVE BEEN MOVING OR TOGGLING, OTHERWISE THE STEM WAS WELL IMPLANTED AND WAS EXTREMELY DIFFICULT TO BE REMOVED.

  Patient problems: Joint Disorder

  MAUDE report 7178499 ↗
• InjuryDec 27, 2017Appropriate Device Problem Term/Code Not Available

  PATIENT HAD PRIMARY SURGERY ON (B)(6) 2017. DURING INSERTION AND IMPACTION OF THE DEFINITIVE IMPLANT (SIZE 1 QUADRAH SN (B)(4)) WITH THE CERAMIC HEAD, THE SURGEON NOTED THAT THE IMPLANT HAD SUNK IN BY APPROXIMATELY 15MM. HE CONTINUED TO BROACH UP AND SETTLED ON A NUMBER 3 BROACH. A SIZE 3 QUADRAH SN (B)(4) WAS OPENED AND INSERTED. XRAY WAS CALLED AND SURGEON WAS SATISFIED WITH RESULT. PATIENT WAS CLOSED AS PER NORMAL PROTOCOLS. ON (B)(6) 2017 IT WAS NOTED THAT THERE WAS A FRACTURE OF THE FEMUR AND A REVISION WAS PLANNED FOR (B)(6) 2017 THIS SURGERY WAS COMPLETED ON (B)(6) 2017 WHERE ABLE WERE PASSED AROUND THE FEMUR TO STABILIZE THE FRACTURE.

  Patient problems: Hip Fracture

  MAUDE report 7147258 ↗

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