C-STEM 1570-04-085Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295059608), received between Oct 3, 2017 and Feb 3, 2026 — classified as 9 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 3, 2026Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THE HIP REVISION PROCEDURE DUE TO MIGRATION OF THE PINNACLE ACETABULAR CUP. THE STEM CAME OUT WHEN THE HEAD WAS REMOVED, THEREFORE THE STEM WAS REPLACED AS WELL. IMPLANTS WERE REPLACED WITH PINNACLE MULTIHOLE SZ 56, +4/10 LINER, 36 +12 CERAMIC HEAD AND C-STEM SZ 2 HIGH OFFSET.

  Patient problems: Insufficient Information

  MAUDE report 24247681 ↗
• InjuryMar 20, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  REVISION OF C-STEM DUE TO UNDER SIZING THE CEMENT MANTLE.

  Patient problems: Insufficient Information

  MAUDE report 18939920 ↗
• InjuryMay 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS WALKING DOWN SOME STEPS OUTSIDE A RESTAURANT AND FELL, UNABLE TO MOBILISE. WAS ADMITTED WITH PERI-PROSTHETIC FRACTURE. PRIMARY OPERATION WAS DONE IN 2015, UNSURE OF EXACT DATE AS WAS PERFORMED AT ANOTHER HOSPITAL. UNABLE TO GET THE PRODUCT NUMBERS FROM THE FEMORAL HEAD AS IT WAS UNABLE TO BE REMOVED FROM THE STEM.

  Patient problems: Fall; Limb Fracture; Loss of Range of Motion

  MAUDE report 11831229 ↗
• InjuryApr 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LEFT TOTAL HIP WHICH HAD BEEN REVISED TO A CEMENT IN CEMENT REVISION ON (B)(6) 2019, REQUIRED THE FEMORAL STEM AND HEAD TO BE REVISED DUE TO FAILURE OF THE CEMENT MANTLE AND LATERAL BONE LOSS IN THE FEMUR. RECLAIM HIP PROSTHESIS WAS USED IN THIS REVISION OPERATION. NOTED INSTABILITY OF THE FEMORAL STEM.

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

  MAUDE report 11665528 ↗
• InjuryJan 15, 2021Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR DISLOCATION AND LOOSE STEM AT THE CEMENT TO IMPLANT INTERFACE. DOI: (B)(6) 2020 DOR: (B)(6) 2021 RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 11179044 ↗
• InjuryJan 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  1. WHAT IS THE AFFECTED SIDE INVOLVED IN THIS EVENT? -UNKNOWN. 2. CAN YOU PLEASE RE-CONFIRM THE DATE THE PATIENT WAS REVISED? -I ATTENDED THIS REVISION ON THURSDAY (B)(6) 2020. THERE IS NO USAGE AS WE DID NOT IMPLANT ANY OF OUR IMPLANTS. 3. RADIOGRAPHS/X-RAY FILMS AND OP NOTES IF AVAILABLE - NOT AVAILABLE. 4. PATIENT DEMOGRAPHICS & COMORBIDITIES -CAUCASIAN FEMALE. OTHER DETAILS NOT AVAILABLE.

  Patient problems: Bone Fracture(s)

  MAUDE report 11148487 ↗
• MalfunctionMar 13, 2020Device Damaged Prior to Use; Tear, Rip or Hole in Device Packaging; Device Damaged Prior to Use; Tear, Rip or Hole in Device Packaging

  THE PLASTIC WRAP IS STILL INTACT HOWEVER THE BOX IS DAMAGED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9832396 ↗
• InjuryNov 6, 2019Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration

  ADDITIONAL INFORMATION RECEIVED INDICATING THAT THE LOOSENING HAPPENED AT CEMENT TO BONE INTERFACE. AS PER SALES REP, THEY ARE UNSURE OF THE CEMENT ORIGINALLY USED IN THE OPERATION.

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

  MAUDE report 9284381 ↗
• InjuryJul 30, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  ASR XL ACETABULAR SYSTEM (RIGHT). THE PATIENT WAS REVISED TO ADDRESS PAIN. DOI: (B)(6) 2006; DOR: (B)(6) 2011; RIGHT HIP.

  Patient problems: Not Applicable; Pain

  MAUDE report 7730822 ↗
• InjuryOct 3, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND STEM SUBSIDENCE.

  Patient problems: Pain

  MAUDE report 6910640 ↗