C-STEM 9613-15-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295236849), received between Oct 23, 2018 and Sep 3, 2026 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Entrapment of Device” (1 report).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjurySep 3, 2026Loss of or Failure to Bond

  Patient problems: Foreign Body Reaction; Pain

  MAUDE report 50591646 ↗
• InjuryNov 30, 2022Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT ON (B)(6) 2012, THE PATIENT UNDERWENT THE PRIMARY SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, PATIENT FELL AND SUFFERED A PERIPROSTHETIC FRACTURE ON AN UNKNOWN DATE. ALTHOUGH THE BONE FRACTURED PART WAS FIXED WITH A PLATE, IT WAS DECIDED TO REPLACE IT AGAIN DUE TO THE LOOSENESS OF THE IMPLANT. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2012. DOR: (B)(6) 2022. UNKNOWN SIDE.

  Patient problems: Fall; Inadequate Osseointegration; Limb Fracture

  MAUDE report 15885997 ↗
• MalfunctionJul 21, 2020Inadequacy of Device Shape and/or Size; Fitting Problem; Inadequacy of Device Shape and/or Size; Fitting Problem

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2020 VIA THA. DURING IMPLANTING, THE SURGEON ASSEMBLED THE STEM AND THE CENTRALIZER, SUPPLIED CEMENT TO FEMUR AND TRIED TO IMPLANT THE STEM APPROPRIATE TIMING, BUT HE COULD NOT IMPLANT THE STEM PROPERLY DEPTH ALTHOUGH HE IMPACTED THE STEM A NUMBER OF TIMES STRONGLY. THE CEMENT CURED SOLIDLY IN THE SETTING OF THE INSUFFICIENCY OF THE STEM¿S IMPLANTING. THE STEM LEFT SEVERAL MILLIMETRES FROM THE PATIENT¿S FEMUR. THE PATIENT¿S LEG LENGTH DID NOT SUIT, THE SURGEON EXPLANTED THE STEM AND IMPLANTED ANOTHER STEM (MANUFACTURED BY ANOTHER COMPANY). THE SURGERY WAS COMPLETED OVER 30 MINUTES DELAY. IT WAS UNKNOWN WHY THE STEM WAS NOT INSERTED COMPLETELY. THE SURGEON WAS SKILLFUL FOR THE SURGICAL TECHNIQUE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Code Available

  MAUDE report 10301657 ↗
• InjuryMar 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2013 VIA THA. IT WAS REPORTED THAT THERE WAS AN INDICATION OF INFECTION FOR SEVERAL YEARS, AND THE SURGEON HAD ADMINISTERED ANTIBIOTIC TO THE PATIENT AND FOLLOWED INFECTION¿S PROGRESS. HOWEVER, ON (B)(6) 2020, THE REMOVAL SURGERY WAS PERFORMED. THE SURGEON REMOVED THE CUP (P/N: 965328047), THE HEAD (P/N: 962734000), THE C-STEM (P/N: 961315000), THE CENTRALIZER (P/N: 961246000), THE END CAP (P/N: 961226000) AND THE CEMENT RESTRICTOR (P/N: 546014000) AND PLACED A CEMENT SPACE MOLDS. THE SURGERY WAS COMPLETED, AND IT WAS UNKNOWN WHETHER THERE WAS A SURGICAL DELAY OR NOT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9900791 ↗
• InjuryFeb 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2009 VIA THA. IT WAS REPORTED THAT THE REMOVAL SURGERY WAS PERFORMED BY EXPLANTING THE CUP (MANUFACTURED BY KYOCERA, P/N: 121780056, LOT#: 00277), THE LINER (P/N: 121887356), THE HEAD (P/N: 962712000) DUE TO SUSPECTED INFECTION CAUSED BY PAIN, AND INDWELLED CEMENT SPACER MOLDS (DATE OF SURGERY WAS UNKNOWN). THE STEM (P/N: 961315000) WAS RETAINED AT THIS TIME, AND THE REVISION SURGERY WAS SCHEDULED TO BE PERFORMED ABOUT 3 MONTHS LATER BY EXPLANTING THE STEM AND IMPLANTING IMPLANTS AFTER CONFIRMING SEDATION OF INFECTION (DATE OF SURGERY WAS NOT FIXED YET). THE STEM IS PLANNING TO BE RETURNED AFTER THE REVISION SURGERY HAS BEEN PERFORMED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Code Available; Not Applicable; Pain; Unspecified Infection

  MAUDE report 9686836 ↗
• InjuryFeb 3, 2020Fracture; Fracture

  REVISION SURGERY: ORIGINAL C STEM IMPLANT, IN SITU FOR APPROXIMATELY TEN YEARS. PLANNED REVISION OF IMPLANT TO DUE IMPLANT FAILURE

  Patient problems: No Code Available

  MAUDE report 9661397 ↗
• InjuryOct 23, 2018Entrapment of Device; Entrapment of Device

  SURGICAL DELAY 30 MINS

  Patient problems: Not Applicable

  MAUDE report 7994739 ↗