SUMMIT 1570-02-070Recalls & reported problems
Depuy Orthopaedics, Inc. · SUMMIT FEMORAL STEM 12/14 TAPER TAPERED w/DUOFIX HA SIZE 1 STD 125mm · Class 2 · Implant
All models of SUMMIT (53)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295059424), received between Jan 14, 2020 and Feb 24, 2025 — classified as 3 injuries.
The most frequently reported specific device problem is “Osseointegration Problem” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Osseointegration Problem1
Patient problems
- No Code Available2
- Test Result2
- Ambulation or Postural Difficulties1
- Depression1
- Discomfort1
- Fall1
- Foreign Body Reaction1
- Inadequate Osseointegration1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryFeb 24, 2025Osseointegration Problem; Osseointegration Problem
PATIENT FELL AND SUFFERED A PERIPROSTHETIC FRACTURE. THERE WAS A LOOSENING REPORTED AT FEMORAL STEM AT NON-CEMENTED INTERFACE. DOI: (B)(6) 2017. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.
Patient problems: Fall; Inadequate Osseointegration; Limb Fracture
MAUDE report 21447593 ↗InjuryMar 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PINNACLE CLAIM SUBMISSION FORM AND MEDICAL RECORD RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, IT WAS REPORTED THAT PATIENT HAD ELEVATED METAL IONS. THERE IS NO LABORATORY RESULT PROVIDED. DOI: (B)(6) 2007 - DOR: NONE REPORTED (LEFT HIP).
Patient problems: No Code Available; Test Result
MAUDE report 9787209 ↗InjuryJan 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ASR MEDICAL RECORD RECEIVED. AFTER REVIEW OF MEDICAL RECORDS THE PATIENT WAS REVISED. HOWEVER, THERE IS NO REASON FOR REVISION PROVIDE ASIDE FROM SYSTEMIC ALLEGATION OF ELEVATED METAL IONS IN THE LEFT HIP. DOI: (B)(6) 2009; DOR: (B)(6) 2011; RIGHT HIP (1ST REVISION).
Patient problems: Ambulation or Postural Difficulties; Depression; Discomfort; Foreign Body Reaction; Metal Related Pathology; No Code Available; Test Result
MAUDE report 9588510 ↗
Other PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED devices
- PINNACLE 1217-25-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED735 reports
- NA 1365-52-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED683 reports
- APEX 1246-03-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED3 deaths613 reports
- PINNACLE 1217-20-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 deaths590 reports
- PINNACLE 1217-30-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 death484 reports
- NA 1365-53-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED404 reports
- PINNACLE ALTRX 1221-36-054Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED388 reports
- PINNACLE ALTRX 1221-32-050Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED386 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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