DJO SURGICAL 315-0A-717Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00888912113922), received between Mar 21, 2017 and Jul 31, 2025 — classified as 12 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

1 other recall cover devices cleared under the same FDA submission (K140830); they may or may not involve this specific model.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryJul 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 22682962 ↗
• InjuryOct 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO INSTABILITY AND PAIN.

  Patient problems: Implant Pain; Joint Laxity

  MAUDE report 18044505 ↗
• InjuryJun 22, 2022Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - DUE TO INSTABILITY.

  Patient problems: Insufficient Information

  MAUDE report 14780970 ↗
• InjuryApr 23, 2021Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY - LOOSENING DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 11716487 ↗
• InjurySep 18, 2020Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - PATIENT FELL WHILE BEING DISCHARGED AND RUPTURED HER PATELLA TENDON.

  Patient problems: Fall; Rupture

  MAUDE report 10553708 ↗
• InjuryMay 23, 2019Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - DUE TO POLY EXCHANGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8637050 ↗
• InjuryMay 10, 2019Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO THE PATIENT ACQUIRING A POST-OPERATIVE INFECTION. THE SURGEON PREFERRED A WASH OUT AND SWAPPED THE POLY.

  Patient problems: Unspecified Infection

  MAUDE report 8600415 ↗
• InjuryMay 21, 2018Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO THE PATIENT FALLING AND RUPTURING THEIR PATELLA TENDON. THE SURGEON SWAPPED THE POLY FOR THE THICKER SIZE. THIS IS THE THIRD REVISION FOR THIS PATIENT.

  Patient problems: Fall; Rupture

  MAUDE report 7531098 ↗
• InjuryFeb 6, 2018Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO THE PATIENT HAVING AN INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 7244116 ↗
• InjuryDec 28, 2017Material Rupture

  REVISION SURGERY - DUE TO THE PATIENT RUPTURING THEIR EXTENSOR MECHANISM. THE SURGEON SWAPPED THE PATIENT'S POLY OUT FOR A 19.5 MM DURING THE PROCEDURE.

  Patient problems: Failure of Implant

  MAUDE report 7151005 ↗
• InjuryOct 17, 2017Patient-Device Incompatibility

  REVISION SURGERY: DUE TO PATIENT HAVING AN INFECTION. THE SURGEON WANTED TO CHANGE THE POLY, WHICH IS PROTOCOL IN THIS SETTING.

  Patient problems: Unspecified Infection

  MAUDE report 6955023 ↗
• InjuryMar 21, 2017Insufficient Device Problem Information

  REVISION SURGERY - DUE TO THE PATIENT HAVING A POST OP INFECTION. THE SURGEON WANTED TO GO AHEAD AND SWAP OUT THE POLY. IT WAS NOT DIRECTLY RELATED TO ANY PATIENT ISSUES.

  Patient problems: Unspecified Infection

  MAUDE report 6421217 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K140830. One submission often covers many models, so check the product and lot details in each record.

• Z-0165-2016 · Sep 16, 2015 · Terminated
  Exprt Precision System: Revision Knee, Model Number 160-010-726/738 For use with the Exprt Knee System in total knee arthroplasty to replace the native patella.