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SUMMIT 1570-06-135Recalls & reported problems

Depuy Orthopaedics, Inc. · SUMMIT FEMORAL STEM 12/14 TAPER BASIC CEMENTED SIZE 7 133mm · Class 2 · Implant

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Adverse event reports
3
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295059806), received between Dec 5, 2019 and Apr 12, 2022 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1
  • Device Contaminated During Manufacture or Shipping1
  • Loss of or Failure to Bond1
  • Tear, Rip or Hole in Device Packaging1

Patient problems

  • No Code Available2
  • Unspecified Infection2
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 12, 2022Tear, 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

    IT WAS REPORTED THAT ON (B)(6), 2022, THE PATIENT UNDERWENT A BHA SURGERY FOR FEMORAL NECK FRACTURE. DURING THE SURGERY, WHEN THE SURGEON TRIED TO OPEN THE PACKAGE OF THE IMPLANT, THE SURGEON FOUND THAT THE PLASTIC PACKAGE ON THE OUTER SIDE OF THE DOUBLE STERILIZATION PACKAGE HAD BEEN BROKEN. THE SURGEON CONSIDERED THAT THERE WAS NO GUARANTEE THAT THE STERILIZATION OF THE IMPLANT HAD BEEN MAINTAINED. THE SURGERY ITSELF WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14087321 ↗
  • InjuryNov 6, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

    THE PATIENT WAS REVISED DUE TO INFECTION AND LOOSENING OF THE FEMORAL STEM AT THE CEMENT TO IMPLANT INTERFACE. COMPETITOR BONE CEMENT WAS USED. IT WAS CONVERTED FROM A HEMI TO A TOTAL HIP REPLACEMENT. NO SURGICAL DELAY NOTED. DOI: (B)(6) 2020, DOR: (B)(6) 2020, LEFT HIP.

    Patient problems: No Code Available; Unspecified Infection

    MAUDE report 10803591 ↗
  • InjuryDec 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PATIENT RECEIVED A HEMI HIP AS TREATMENT FOR A FEMORAL NECK FRACTURE ON (B)(6) 2019. THIS IMPLANT BECAME INFECTED AND THE PATIENT WAS BROUGHT TO SURGERY TODAY FOR REVISION. DOI: (B)(6) 2019. DOR: (B)(6) 2019. LEFT HIP.

    Patient problems: No Code Available; Unspecified Infection

    MAUDE report 9417836 ↗

Other Prosthesis, hip, semi-constrained, metal/polymer, cemented devices

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Sources and updates

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