SUMMIT 1570-05-080Recalls & reported problems
Depuy Orthopaedics, Inc. · SUMMIT FEMORAL STEM 12/14 TAPER BASIC PRESS-FIT SIZE 2 130mm · Class 2 · Implant
All models of SUMMIT (53)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295059684), received between Jul 26, 2017 and Jan 19, 2018 — classified as 2 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.
Most reported problems
Device problems
- Insufficient Device Problem Information1
- Loose or Intermittent Connection1
Patient problems
- Bone Fracture(s)1
- Inadequate Osseointegration1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 19, 2018Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT THE STEM WAS NOT STABLE AND WAS EXPLANTED. IT WAS INDICATED THAT THERE WAS LOOSENING OF THE STEM AT THE BONE TO IMPLANT INTERFACE. DOE (B)(6) 2017, RIGHT HIP.
Patient problems: Inadequate Osseointegration
MAUDE report 7205407 ↗InjuryJul 26, 2017Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT HAD A HEMI HIP AT UNKNOWN DATE AND ALSO HAD A REVISION WITH CABLE PLATE AND CABLES AND SCREWS AT UNKNOWN DATE. WHEN WE ARRIVED TO THIS CASE PATIENT HAD FRACTURED AGAIN. THE SURGEON REMOVED CABLES AND PLATE AND SCREW REMOVED FRACTURE STEM AND REPLACED IT WITH A 8' SOLUTION STEM PUT ANOTHER PLATE AND SCREWS ON THE FEMUR AND PUT A NEW UNI-POLAR HEAD ON.
Patient problems: Bone Fracture(s)
MAUDE report 6744225 ↗
Other Prosthesis, hip, semi-constrained, metal/polymer, cemented devices
- NA 1365-51-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented753 reports
- NA 1365-50-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented412 reports
- ARTICUL/EZE 1365-21-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall280 reports
- ARTICUL/EZE 1365-11-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 death262 reports
- LFIT 6260-9-236Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, cemented256 reports
- 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
- Novation 130-36-52Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2 recalls124 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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