SUMMIT 1570-06-110Recalls & reported problems
Depuy Orthopaedics, Inc. · SUMMIT FEMORAL STEM 12/14 TAPER BASIC CEMENTED SIZE 5 121mm · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295059783), received between Aug 7, 2017 and Jun 28, 2024 — classified as 5 injuries, 1 malfunction.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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
- Insufficient Device Problem Information2
- Loss of or Failure to Bond2
- Adverse Event Without Identified Device or Use Problem1
- Device Contaminated During Manufacture or Shipping1
- Tear, Rip or Hole in Device Packaging1
Patient problems
- Bone Fracture(s)2
- Not Applicable2
- Fall1
- Fibrosis1
- Fracture, Arm1
- No Clinical Signs, Symptoms or Conditions1
- No Information1
- Unspecified Infection1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 28, 2024Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping; Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping
OPENED STERILE EXTERIOR PACKAGING TO DAMAGED INTERIOR STERILE PACKAGING. MAKING IMPLANT NOT STERILE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19639013 ↗InjuryMay 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD A HEMI DONE IN (B)(6) 2021, PATIENT IS INFECTED. REMOVED IMPLANTS AND CEMENTED IN ANOTHER HEMI WITH ANTIBIOTIC IMPREGNATED CEMENT. I HAVE NO OTHER INFORMATION. THERE IS NO REPORTED LOOSENING. NO SURGICAL DELAY REPORTED. DOI:(B)(6) 2021. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.
Patient problems: Unspecified Infection
MAUDE report 14307137 ↗InjuryJun 7, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
DER STATES THAT THE REVISION HAD NOTHING TO DO WITH IMPLANT FAILURE. THE REASON FOR REVISION IS PATIENT FELL DOWN, SMALL BREAK IN THE FEMUR. NO INSTRUMENTS WERE BROKEN DURING THE SURGERY. DOI: UNKNOWN; DOR: (B)(6) 2018; LEFT HIP.
Patient problems: Bone Fracture(s); Fracture, Arm; Not Applicable
MAUDE report 7577490 ↗InjuryMay 25, 2018Loss of or Failure to Bond; Loss of or Failure to Bond
DER STATES THAT THIS PATIENT'S HIP WAS REVISED DUE TO ASEPTIC LOOSENING OF THE SUMMIT BASIC CEMENTED FEMORAL STEM AT THE CEMENT TO IMPLANT INTERFACE, DEPUY CEMENT WAS USED. FIBEROUS TISSUE BETWEEN THE STEM AND ITS SURROUNDING CEMENT MANTEL WAS OBSERVED BY SURGEON DURING THE REVISION PROCEDURE. HE SEEMED TO THINK THAT THE STEM MAY HAVE BEEN INADVERTENTLY MOVED BEFORE THE CEMENT WAS FULLY HARDENED, CREATING SPACE BETWEEN THE IMPLANT AND THE CEMENT. THE HEMIARTHROPLASTY HIP WAS CONVERTED TO A TOTAL HIP. DOI: (B)(6) 2017; DOR: (B)(6) 2018; RIGHT HIP.
Patient problems: Fibrosis; Not Applicable
MAUDE report 7544144 ↗InjurySep 6, 2017Loss of or Failure to Bond; Loss of or Failure to Bond
THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE STEM. LOOSENING OCCURED AT IMPLANT TO CEMENT INTERFACE. DEPUY CEMENT WAS USED.
Patient problems: No Information
MAUDE report 6846216 ↗InjuryAug 7, 2017Insufficient Device Problem Information; Insufficient Device Problem Information
THE PATIENT WAS REVISED TO ADDRESS PERIPROSTHETIC FRACTURE DUE TO FALL. STEM AND HEAD WERE TAKEN OUT AND REPLACED BY A LONGER STEM.
Patient problems: Bone Fracture(s); Fall
MAUDE report 6770864 ↗
Other Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented devices
- BIOLOX DELTA 1365-32-310Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented551 reports
- PINNACLE ALTRX 1221-36-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented481 reports
- BIOLOX DELTA 1365-32-320Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death314 reports
- BIOLOX DELTA 1365-36-720Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death189 reports
- DJO SURGICAL 400-03-362Encore Medical, L.P. · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented187 reports
- Anthology 71365705Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented176 reports
- BIOLOX DELTA 1365-40-710Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented170 reports
- PINNACLE GRIPTION 1217-32-054Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented169 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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