Quadra C femoral stemsRecalls & reported problems across all models

We found 11 models of Quadra C femoral stems by Medacta International SA in the FDA's device registry (GUDID). Together they are named in 21 adverse event reports in the FDA's MAUDE database, received between Jun 28, 2017 and Feb 5, 2025 — classified as 19 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (5 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Quadra C femoral stems problems

Quadra C femoral stems models

11 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Quadra C femoral stems 01.12.040

  Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
  4 reports
• Quadra C femoral stems 01.12.041

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
  4 reports
• Quadra C femoral stems 01.12.043

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
  4 reports
• Quadra C femoral stems 01.12.044

  Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
  2 reports
• Quadra C femoral stems 01.12.042

  Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
  1 report
• Quadra C femoral stems 01.12.045

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
  1 report
• Quadra C femoral stems 01.12.046

  Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
  1 report
• Quadra C femoral stems 01.12.052

  Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
  1 report
• Quadra C femoral stems 01.12.055

  Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
  1 report
• Quadra C Femoral Stems 01.12.41SN

  Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
  1 report
• Quadra C Femoral Stems 01.12.43SN

  Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
  1 report

Recent Quadra C femoral stems adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryFeb 5, 2025Fracture; Fracture

  THE PATIENT HAD PRIMARY SURGERY IN 2016. FIRST REVISION SURGERY PERFORMED IN 2020 DUE TO STEM LOOSENING. THE SURGEON REVISED THE CEMENTLESS STEM AND IMPLANTED A CEMENTED STEM (QUADRA-C). SECOND REVISION SURGERY PERFORMED ON (B)(6)2021 DUE TO RECURRED LUXATION OF THE HIP JOINT. THE SURGEON REVISED THE INSERT AND THE HEAD, IMPLANTING A MERETE BIO-BALL SIZE 3XL SLEEVE AND 32MM HEAD (OFF-LABEL). SUBSEQUENTLY, THE PATIENT HAD PAIN IN THE HIP AFTER A ROTATING MOVEMENT OF THE LEG. NO TRAUMA REPORTED. THIS RESULTED IN A FRACTURE OF THE NECK OF THE PROSTHESIS. ON (B)(6)2024, THE PATIENT UNDERWENT A THIRD REVISION SURGERY.

  Patient problems: Implant Pain

  MAUDE report 21312822 ↗
• InjurySep 25, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  REVISION SURGERY PERFORMED ABOUT 1 YEAR AND 6 MONTHS AFTER PRIMARY SURGERY DUE TO INFECTION. ALL COMPONENTS REVISED.

  Patient problems: Medical device site infection

  MAUDE report 20299957 ↗
• InjuryApr 4, 2024Migration; Migration

  AT 5 YEARS AND 10 MONTHS FROM THE PRIMARY, REVISION SURGERY DUE TO STEM SUBSIDENCE AND CONSEQUENT LOOSENING. STEM, HEAD AND LINER SUCCESSFULLY REVISED WITH COMPETITORS IMPLANTS.

  Patient problems: Inadequate Osseointegration

  MAUDE report 19040598 ↗
• InjuryNov 28, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT PRESENTED WITH A PERIPROSTHETIC FEMORAL FRACTURE ABOUT 1 MONTH AFTER THE PRIMARY SURGERY. THE SURGEON REPLACED THE STEM AND HEAD WITH NON-MEDACTA IMPLANTS BUT LEFT THE CUP AND LINER IN SITU. HE COULD NOT CONFIRM WHAT CAUSED THE FRACTURE OR WHEN THE FRACTURE OCCURRED.

  Patient problems: Bone Fracture(s)

  MAUDE report 15869293 ↗
• InjuryDec 23, 2021Loose or Intermittent Connection

  REVISION SURGERY WAS PERFORMED 2 YEARS AND 3 MONTHS AFTER THE PRIMARY SURGERY DUE TO STEM MOBILIZATION. THE PATIENT ISN´T A SPORTY PERSON. USES CRUTCHES FOR YEARS, PUTS LITTLE STRAIN ON THE LEG.

  Patient problems: Joint Laxity

  MAUDE report 13078028 ↗
• InjuryJan 18, 2021Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2020, ONE MONTH AFTER THE PRIMARY SURGERY A WASHOUT WAS PERFORMED, ON (B)(6)2020, THE SURGEON PERFORMED AGAIN A WASHOUT AND REVISED THE LINER AND HEAD DUE TO INFECTION. BLOOD CULTURE STILL POSITIVE FOR E COLI. THE SURGEON FINALLY REVISED ALL IMPLANTS ON (B)(6) 2021 VIA POSTERIOR APPROACH AND IMPLANTED COMPETITOR IMPLANTS.

  Patient problems: Bacterial Infection

  MAUDE report 11185283 ↗
• InjuryJul 22, 2020Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY PERFORMED DUE TO STEM SUBSIDENCE 1 YEAR AND 6 MONTHS AFTER PRIMARY.

  Patient problems: Joint Disorder

  MAUDE report 10307068 ↗
• InjuryMar 18, 2020Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  HIP REVISION AFTER 3 YEARS AND 7 MONTHS FROM THE PRIMARY DUE TO STEM LOOSENING AND INFECTION SUSPICIOUS. ALL IMPLANTS WERE REVISED, NO INFECTION PRESENT.

  Patient problems: Joint Disorder

  MAUDE report 9848075 ↗
• InjuryOct 17, 2019Appropriate Device Problem Term/Code Not Available

  THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2018. SUBSEQUENTLY, ON (B)(6) 2018, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN WAS IDENTIFIED AS STREPTOCOCCUS. THE SURGEON PERFORMED AN I&D AND REVISED THE STEM, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. COMPLAINT 1839-18 WAS FILED. ON (B)(6) 2019, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION. THE SURGEON PERFORMED AN I&D AND ALL IMPLANTS WERE EXPLANTED AND THE SURGEON IMPLANTED A HEAD, STEM, AND LINER WITH ANTIBIOTICS. PRESENTLY, ON (B)(6) 2019, THE PATIENT CAME IN TO HAVE PERMANENT HARDWARE IMPLANTED. THE SURGEON REMOVED THE MEDACTA HEAD, STEM, AND LINER THAT ACTED AS A SPACER AND IMPLANTED PERMANENT HARDWARE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 9202083 ↗
• InjuryJul 29, 2019Fracture

  THE PATIENT HAD A TOTAL HIP REPLACEMENT (B)(6) 2017 WHICH HAD TO BE REVISED ON THE (B)(6) 2017 DUE TO FRACTURE (NO IMPLANTS HAS BEEN REMOVED). THE PATIENT THEN SUFFERED FROM AN INFECTION WHICH RESULTED IN ALL IMPLANTS NEEDED TO BE EXTRACTED ((B)(6) 2018). ON (B)(6) 2019 ALL IMPLANTS WERE REMOVED DUE TO INFECTION, PATHOGEN UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 8835298 ↗
• InjuryMar 20, 2019Loosening of Implant Not Related to Bone-Ingrowth

  ON (B)(6) 2019 WE WERE INFORMED ABOUT A PATIENT WHO CAME IN COMPLAINING OF PAIN 4 YEARS AND 8 MONTHS AFTER THE PRIMARY SURGERY DUE TO AN ASEPTIC LOOSENING OF THE STEM AND A LOOSE CUP. THE CAUSE OF THE LOOSE CUP IS UNKNOWN. ON THE FOLLOWING DAY, THE SURGEON REVISED THE CUP, LINER, HEAD AND STEM AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 8436664 ↗
• InjuryFeb 6, 2019Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS SEPTIC SO THE SURGEON REVISED ALL IMPLANTED DEVICES TWO MONTHS AFTER PRIMARY SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8310175 ↗
• InjuryOct 31, 2018Fracture; Difficult to Remove; Mechanical Jam; Positioning Problem

  DURING SURGERY THE SURGEON TRIALED THE FINAL IMPLANT. THE FEMORAL CANAL WAS VERY TIGHT. THE SURGEON WAS ONLY ABLE TO GET DOWN THE 0 QUADRA BROACH. HE THEN WENT TO PUT DOWN THE SMALLEST CEMENT RESTRICTOR AND IT GOT STUCK - WOULD NOT BUDGE. SO HE TRIED TO SEE IF THE 0 CEMENTED IMPLANT WOULD FIT DOWN (PRIOR TO CEMENTING) AND TAPPED IT A FEW TIMES WITH THE INSERTOR; THEN HE COULD NOT GET THE IMPLANT OUT AS THE SCREW IN EXTRACTOR WAS NOT IN THE SET. AS THE PATIENT WAS A LOW DEMAND NURSING HOME THE SURGEON ELECTED TO LEAVE THE CEMENTED STEM IN UNCEMENTED AND ACT AS A PURE WEDGE. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT DID WELL FOR 2 MONTHS UNTIL SHE FELL AND FRACTURED THE LESSER TROCHANTER. DURING THE REVISION THE STEM EASILY CAME OUT. SURGEON'S PLAN WAS TO CABLE THE FX AND CEMENT IN A SMALLER PROSTHESIS. HE CEMENTED THE 0 QUADRA AFTER PLACING 3 CABLES (2 ON THE LESSER PIECE AND ONE IN THE SUBTROCHANTERIC AREA TO PREVENT ANY EXTENSION).

  Patient problems: Joint Disorder

  MAUDE report 8023979 ↗
• InjuryOct 3, 2018Microbial Contamination of Device

  THE PATIENT INITIALLY HAD A COMPETITOR STEM AND CUP IMPLANTED WHICH WAS REVISED FOR INFECTION. THE SURGEON IMPLANTED A QUARDA C STEM AND VERSACEM/DM CONSTRUCT IN AS A 1ST STAGE REVISION (B)(6) 2018. THE INFECTION REMAINED ACTIVE AND THE PATIENT HAD A POST OPERATIVE FEMORAL FRACTURE. THE PATIENT WAS BOOKED FOR ANOTHER SURGERY TO REMOVE COMPONENTS AND REPAIR FRACTURE. FRACTURE WAS NOT REPAIRED DUE TO PATIENT BLEEDING UNCONTROLLABLY. PATIENT TRANSFERRED TO ANOTHER HOSPITAL.

  Patient problems: Bone Fracture(s); Hemorrhage/Blood Loss/Bleeding; Unspecified Infection

  MAUDE report 7929613 ↗
• InjuryJun 26, 2018Device Dislodged or Dislocated

  REVISION SURGERY AFTER ABOUT 6 YEARS AND 8 MONTHS FROM THE PRIMARY DUE TO STEM MOBILIZATION. STEM, HEAD AND LINER WERE REVISED.

  Patient problems: Joint Disorder

  MAUDE report 7637646 ↗

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