C-STEM 1570-14-090Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295060307), received between Dec 14, 2017 and Jun 4, 2026 — classified as 9 injuries.

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJun 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2026. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 25392851 ↗
• InjuryOct 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS VACATIONING AND HAD TAKEN SOME PAIN MEDICINES AT THE HOTEL AT NIGHT. AT SOME POINT SHE DISLOCATED THAT NIGHT. PATIENT WAS BROUGHT TO THE LOCAL HOSPITAL WHERE THEY ATTEMPTED TO REDUCE THE HIP AND CAUSE A PERI PROSTHETIC HIP FX. IT WAS REPORTED THAT STEM WAS REMOVED AND REPLACED AND THE CUP WAS CONVERTED FROM A POLY LINER TO DUAL MOBILITY. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Limb Fracture

  MAUDE report 20426319 ↗
• InjurySep 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL AND FRACTURED FEMUR. STEM, HEAD AND LINER WERE REPLACED. DOI: JAN 4, 2021. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Fall; Limb Fracture

  MAUDE report 17834675 ↗
• InjuryOct 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF A C-STEM FOR PERIPROSTHETIC FRACTURE. ONLY THE HEAD AND STEM WERE REMOVED. LINER AND CUP WERE NOT REVISED. AFTER THE STEM AND HEAD WERE REMOVED THEY ATTACHED A LCP PLATE TO THE FEMUR AND CABLED IT. WE THEN DID A CEMENT IN CEMENT REVISION AND IMPLANTED A NEW C-STEM AND HEAD. PRIMARY SURGERY WAS DONE ON (B)(6) 2022. UNSURE OF THE REASON FOR PERIPROSTHETIC FRACTURE.

  Patient problems: Fall; Joint Laxity; Limb Fracture

  MAUDE report 15649317 ↗
• InjuryJan 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION. CSTEM/PINNACLE TOTAL HIP CONSTRUCT WAS REMOVED AND REPLACED IT WITH A PROSTALAC SPACER. THERE WAS LOOSENING OF AN UNKNOWN CONSTRUCT AT THE BONE TO CEMENT INTERFACE. DOI: (B)(6) 2020. DOR: (B)(6) 2022 (LEFT HIP).

  Patient problems: Unspecified Infection

  MAUDE report 13342019 ↗
• InjuryNov 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF A C-STEM DUE TO A PERIPROSTHETIC FRACTURE. PATIENT HAD A FALL. C-STEM AND CERAMIC HEAD WERE EXPLANTED, AND A RECLAIM STEM WAS IMPLANTED. THE FRACTURE WAS CABLED PRIOR THE PREPARING FOR RECLAIM. THE CERAMIC HEAD 136536320 36 +5 WAS ALSO REMOVED WITH THE STEM.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 10898820 ↗
• InjuryDec 5, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  REVISED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 8135088 ↗
• InjuryDec 14, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  NEW UNITY RECORD CREATED IN ORDER TO UPDATE LEGACY COMPLAINT NUMBER (B)(4). ASR REVISION; ASR XL - RIGHT; REASON(S) FOR REVISION: ALVAL / SOFT TISSUE REACTION, PAIN AND ELEVATED COBALT LEVELS. FNOL - DEP - (B)(4). DOI: (B)(6) 2007; DOR: (B)(6) 2013.

  Patient problems: Foreign Body Reaction; Pain

  MAUDE report 7117139 ↗
• InjuryDec 14, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  NEW UNITY RECORD CREATED IN ORDER TO UPDATE LEGACY COMPLAINT NUMBER (B)(4). ASR REVISION TO TAKE PLACE ON (B)(6) 2013. ASR XL ACETABULAR SYSTEM - LEFT. REASON(S) FOR REVISION: PAIN; ALVAL/ SOFT TISSUE REACTION - PSEUDO MASS; ELEVATED COBALT AND CHROME LEVELS. (B)(4) REFERENCE NUMBER: (B)(4). UPDATE NOV 17, 2017: EMAIL NOTIFICATION FROM (B)(6)'S RECEIVED. UPDATED COMPLAINANT INFORMATION. DOI: (B)(6) 2007, DOR: (B)(6) 2013.

  Patient problems: Foreign Body Reaction; Local Reaction; Pain; Test Result

  MAUDE report 7116500 ↗