SUMMIT 1570-13-100Recalls & reported problems
Depuy Orthopaedics, Inc. · SUMMIT FEMORAL STEM 12/14 TAPER CEMENTED SIZE 4 HI 114mm · Class 2 · Implant
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295060239), received between Sep 11, 2018 and Oct 6, 2023 — classified as 10 injuries, 1 malfunction.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (4 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.
Reports received per month
Most reported problems
Device problems
- Loss of or Failure to Bond4
- Adverse Event Without Identified Device or Use Problem2
- Corroded1
- Fracture1
- Loose or Intermittent Connection1
- Loss of Osseointegration1
- Tear, Rip or Hole in Device Packaging1
Patient problems
- Inadequate Osseointegration2
- Insufficient Information2
- Limb Fracture2
- No Code Available2
- Unspecified Infection2
- Bone Fracture(s)1
- Discomfort1
- Fall1
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
InjuryOct 6, 2023Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO THE STEM ALONG WITH CEMENT MANTLE WAS LOOSE. DOI: (B)(6) 2021 DOR: (B)(6) 2023 AFFECTED SIDE : LEFT HIP.
Patient problems: Insufficient Information
MAUDE report 17886176 ↗InjuryMay 4, 2023Loss of or Failure to Bond; Loss of or Failure to Bond
CLINICAL ADVERSE EVENT RECEIVED FOR FAILED CEMENT MANTLE. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO DEVICE. EVENT IS NOT RELATED TO PROCEDURE. DATE OF IMPLANT: 23 AUG 2013 DATE OF EVENT: 17 APR 2023 (RIGHT HIP) TREATMENT: AWAITING REVISION.
Patient problems: Insufficient Information
MAUDE report 16867425 ↗InjuryMay 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT EXPERIENCED A PERI-PROSTHETIC FRACTURE OF HER RIGHT FEMUR DUE TO A FALL. THE EXISTING IMPLANTS WERE REMOVED AND A RECLAIM STEM CONSTRUCT WAS UTILIZED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6)2013. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.
Patient problems: Fall; Limb Fracture
MAUDE report 16857094 ↗InjuryFeb 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO INFECTED HIP WITH SPACER. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.
Patient problems: Unspecified Infection
MAUDE report 16350289 ↗InjuryNov 4, 2022Loss of or Failure to Bond; Loss of or Failure to Bond
PATIENT WAS REVISED DUE TO PROXIMAL FEMORAL FRACTURE SO THE SURGEON REMOVED STEM AND DID PROXIMAL FEMORAL REPLACEMENT. SURGEON RETAINED ASSET SIDE. LOOSENING WAS REPORTED. NO ADDITIONAL INFORMATION WAS REPORTED. DOI: (B)(6) 2018. DOR: (B)(6) 2022. AFFECTED SIDE: UNKNOWN.
Patient problems: Limb Fracture
MAUDE report 15728658 ↗MalfunctionDec 30, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
THE WHITE TOP WRAPPER ON THE OUTSIDE OF THE STEM TRAY PACKAGING HAD A TEAR IN IT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13119227 ↗InjuryMay 28, 2019Loss of or Failure to Bond; Loss of or Failure to Bond
ADDITIONAL INFORMATION RECEIVED INDICATING THAT LOOSENING INTERFACE IS CEMENT TO IMPLANT.
Patient problems: No Code Available
MAUDE report 8645679 ↗InjuryFeb 27, 2019Fracture; Fracture
PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES INFECTION AND BONE FRACTURE AFTER FIRST REVISION. DOI: (B)(6) 2014; DOR: (B)(6) 2014; (LEFT HIP).
Patient problems: Bone Fracture(s); No Code Available; Unspecified Infection
MAUDE report 8374020 ↗InjuryNov 20, 2018Loose or Intermittent Connection; Loose or Intermittent Connection
PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES LOOSENING OF STEM.
Patient problems: Inadequate Osseointegration
MAUDE report 8089652 ↗InjuryNov 1, 2018Corroded; Corroded
LITIGATION ALLEGES CORROSION, PAIN, AND ELEVATED METAL IONS. DOI: (B)(6) 2006 - DOR: NONE REPORTED (LEFT HIP).
Patient problems: Discomfort; Inflammation; Pain; Test Result
MAUDE report 8028103 ↗InjurySep 11, 2018Loss of Osseointegration; Loss of Osseointegration
REVISION TOTAL HIP REPLACEMENT: (B)(6) HOSPITAL, (B)(6) 2018. PRIMARY IMPLANT (B)(6) 2012. THE STEM HAD SUBSIDED AND WAS LOOSE, THIS WAS EVIDENT ON X-RAY. THE STEM, HEAD, SCREWS AND LINER WERE REMOVED AND REPLACED. A CONSERVATIVE REVISION WAS COMPLETED. MALE PATIENT (B)(6).
Patient problems: Inadequate Osseointegration; Not Applicable
MAUDE report 7864716 ↗
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- PINNACLE GRIPTION 1217-32-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented2 deaths239 reports
- ELEOS™ 25002111EOnkos Surgical, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented3 deaths230 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.