SUMMIT 1570-06-090Recalls & reported problems
Depuy Orthopaedics, Inc. · SUMMIT FEMORAL STEM 12/14 TAPER BASIC CEMENTED SIZE 3 108mm · Class 2 · Implant
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295059769), received between Aug 25, 2017 and May 8, 2025 — classified as 9 injuries.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (7 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 Bond7
- Adverse Event Without Identified Device or Use Problem1
- Insufficient Device Problem Information1
Patient problems
- Not Applicable3
- No Code Available2
- Pain2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Fall1
- No Consequences Or Impact To Patient1
- No Information1
- Unspecified Infection1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
InjuryMay 8, 2025Loss of or Failure to Bond; Loss of or Failure to Bond
THAYER SCHOOL OF ENGINEERING AT DARTMOUTH FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q1 OF 2025. DARTMOUTH IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: REVISION DUE TO LOOSE FEMORAL STEM AND PAIN. AT REMOVAL THERE WAS CORROSION ON THE HEAD.
Patient problems: Pain
MAUDE report 21984162 ↗InjuryJul 26, 2024Loss of or Failure to Bond; Loss of or Failure to Bond
(B)(6) FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q2 OF 2024. IT WAS REPORTED REVISION WAS COMPLETED DUE TO IMPLANT LOOSENING.
Patient problems: Pain
MAUDE report 19839225 ↗InjuryAug 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT RESECTION ARTHROPLASTY / GIRDLESTONE DUE TO INFECTION. NOTHING REIMPLANTED. NO ADDITIONAL INFORMATION. DOI: (B)(6) 2014 DOR: (B)(6) 2021 LEFT HIP.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 12301557 ↗InjuryMay 8, 2020Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED THAT RECEIVED PATIENT FALL. IMPLANT DISLOCATION DUE TO DISASSOCIATION FROM CEMENT. IMPLANT WAS EASILY REMOVED AND CAME OUT FREE OF ANY CEMENT. DOI: UNKNOWN. DOR: (B)(6) 2020; LEFT SIDE.
Patient problems: Fall; No Code Available
MAUDE report 10039146 ↗InjuryApr 9, 2020Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED THAT PATIENT HAD HEMI HIP ON (B)(6) 2020. HIP DISLOCATED AND STEM WAS LOOSE IN CEMENT MANTLE.
Patient problems: No Code Available
MAUDE report 9943561 ↗InjuryApr 4, 2019Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED THAT THE SURGEON IMPLANTED SIZE 3 SUMMIT BASIC CEMENTED STEM# 1570-06-090 USING COMPETITOR CEMENT. STEM CAME LOOSE AT CEMENT TO IMPLANT INTERFACE AFTER CEMENTING DURING SURGERY MOST LIKELY DUE TO IMPLANTING THE COMPETITOR CEMENT TOO LATE. SURGEON INSTEAD IMPLANTED A SIZE 2 STEM AND MADE A NEW CEMENT MANTLE WITH SIMPLEX AND SURGERY WAS SUCCESSFULLY COMPLETED. DOE: (B)(6) 2019. UNKNOWN AFFECTED SIDE.
Patient problems: No Consequences Or Impact To Patient; Not Applicable
MAUDE report 8483477 ↗InjuryAug 10, 2018Loss of or Failure to Bond; Loss of or Failure to Bond
THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE CEMENTED HEMI STEM AT CEMENT TO IMPLANT INTERFACE. SURGEON REMOVED ALL COMPONENTS AND DID REVISION. DOI: (B)(6) 2017; DOR: (B)(6) 2018; RIGHT HIP.
Patient problems: Not Applicable
MAUDE report 7772071 ↗InjuryApr 30, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
DER STATED THAT THE PATIENT HAS AN INFECTED CEMENTED HEMIARTHROPLASTY HIP. IT WAS DONE IN (B)(6) 2018. THE SURGEON REMOVED THE COMPONENTS AND IMPLANTED TEMPORARY PARTS UNTIL THE INFECTION IS GONE. THE PATIENT IS STABLE. DOI: (B)(6) 2018; DOR: (B)(6) 2018; LEFT HIP. NO SURGICAL DELAY.
Patient problems: Not Applicable; Unspecified Infection
MAUDE report 7471847 ↗InjuryAug 25, 2017Loss of or Failure to Bond; Loss of or Failure to Bond
PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE STEM AT CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURING IS UNKNOWN.
Patient problems: No Information
MAUDE report 6820058 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.