C-STEM 1570-14-085Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295060291), received between Jan 10, 2018 and Aug 11, 2026 — classified as 12 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (3 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, 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryAug 11, 2026Fracture

  It was reported that the distal part of the implant (stem) broke; periprosthetic fracture after two years in-situ. The hip was revised. All pieces were recovered. There was no surgical delay.

  Patient problems: Limb Fracture

  MAUDE report 50209588 ↗
• InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient needed revision due to instabilityDOI: (b)(6), 2019DOR: (b)(6), 2026Affected side: Left hip

  Patient problems: Joint Laxity

  MAUDE report 50061391 ↗
• InjurySep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PERI-PROSTHETIC FRACTURE WAS DISCOVERED WITH C-STEM AMT IMPLANT. THE ORIGINAL PROCEDURE OCCURRED OVER FIVE (5) YEARS AGO. THE IMPLANTS WERE REVISED.

  Patient problems: Limb Fracture

  MAUDE report 22965498 ↗
• InjuryJul 1, 2025Fracture; Fracture

  IT WAS REPORTED THAT A BROKEN CSTEM IMPLANT WAS BEING REVISED. IT HAS BEEN IN FOR 12 YEARS.PATIENT REQUIRED A REVISION SURGERY TO IMPLANT NEW PROTHESIS.

  Patient problems: Insufficient Information

  MAUDE report 22374032 ↗
• InjuryNov 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AS "OUTSIDE HOSPITAL, NO DATA ON LOTS OR PRIOR SURGERY DATE. PERI-PROSTHETIC FX AROUND STEM. CAN'T READ LOT NUMBERS ON PLASTIC OR HEAD. THIS IS ALL THE INFO I HAVE. DOI: UNKNOWN, DOR: (B)(6) 2021, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Limb Fracture

  MAUDE report 12738385 ↗
• InjuryAug 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2021, DOR: (B)(6) 2021. AFFECTED SIDE: LEFT HIP.

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

  MAUDE report 12360274 ↗
• InjuryJan 18, 2021Fracture; Fracture

  IT WAS INITIALLY REPORTED THAT IMPLANT WAS RECEIVED AS A BLIND UNIT. REVISION TO ADDRESS IMPLANT FRACTURE POST OP: METAL. DOI: UNKNOWN; DOR: UNKNOWN; HIP UNKNOWN. INVESTIGATIONS ARE BEING CONDUCTED.

  Patient problems: Insufficient Information

  MAUDE report 11185533 ↗
• InjuryAug 17, 2020Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATED THAT THE REPLACEMENT WAS DUE TO A FRACTURED NECK OF FEMUR SUSTAINED AFTER A FALL FROM OWN HEIGHT. SURGERY TIME WAS NOT EXTENDED.

  Patient problems: Bone Fracture(s); Fall; No Code Available

  MAUDE report 10415218 ↗
• InjuryJul 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFFECTED SIDE IS THE RIGHT.

  Patient problems: Bone Fracture(s); Fall; No Code Available

  MAUDE report 10254682 ↗
• InjurySep 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL AND HAD A PERIPROSTHETIC HIP REVISION. THE HEAD, LINER AND STEM WERE REMOVED IN ORDER TO ADDRESS THE FRACTURE. A COMPETITOR STEM AND HEAD WERE USED IN THE REVISION. DOI: (B)(6) 2017; DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: No Code Available

  MAUDE report 9136057 ↗
• InjurySep 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL AND HAD A PERIPROSTHETIC FRACTURE BELOW THE STEM. HAD TO REMOVE SO THAT WE COULD ADD A LONGER STEM PAST THE FRACTURE. DOI: (B)(6) 2019. DOR: (B)(6) 2019. LEFT HIP.

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 8977127 ↗
• MalfunctionMar 26, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  UPDATED CODE FOR STEM BY REMOVING OSSEOINTEGRATION UNDER PATIENT CODE AND CHANGED PRODUCT EXPERIENCE CODE TO IMPLANT LOOSENING.

  Patient problems: Inadequate Osseointegration; Inflammation; Injury; No Code Available; Pain; Weakness

  MAUDE report 8451385 ↗
• InjuryJan 10, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  REVISION THR DUE TO PERIPROSTHETIC FRACTURE, DR. (B)(6), (B)(6) HOSPITAL, (B)(6) 2017. PATIENT UNDERWENT PRIMARY THR ON (B)(6) 2017 -DR. (B)(6). PATIENT WAS DOING WELL UNTIL A FALL 2 DAYS AGO. X RAYS INDICATE A PERI PROSTHETIC FRACTURE. THE FEMORAL STEM AND CEMENT WAS REMOVED AND A RECLAIM REVISION STEM IMPLANTED. THE PINNACLE CUP AND LINER WERE LEFT IN SITU. THE FRACTURE SIGHT WAS CIRCLAGED WITH A NUMBER OF CABLES. MALE PATIENT (B)(6). DOI; (B)(6) 2017; DOR: (B)(6) 2017; UNKNOWN AFFECTED SIDE.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 7178273 ↗