DJO SURGICAL 315-0A-714Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00888912113915), received between Jul 27, 2016 and Apr 8, 2024 — classified as 17 injuries.

The most frequently reported specific device problem is “Material Rupture” (3 reports).

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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryApr 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO PATIENT FELL AND OPENED UP HER ARTHROTOMY FROM SKIN TO IMPLANTS. DID IRRIGATION AND DEBRIDEMENT AND REPLACED POLY WITH STERILE SUBSTITUTE.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 19068587 ↗
• InjuryNov 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - MDR - PAIN/INFECTION.

  Patient problems: Arthralgia; Unspecified Infection

  MAUDE report 18213165 ↗
• InjuryNov 20, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO INSTABILITY.

  Patient problems: Joint Laxity

  MAUDE report 18179055 ↗
• InjuryOct 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - THE REVISION WAS DONE TO ADD A PATELLA. SURGEON DECIDED TO SWAP OUT THE INSERT WHILE HE WAS IN THERE. SURGEON ASKED THE REP IF THERE WERE SIGNS OF INFECTION, BUT HE SAID ALL THE PATIENT'S LEVELS WERE GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15524554 ↗
• InjurySep 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO INSTABILITY.

  Patient problems: Joint Laxity

  MAUDE report 15380663 ↗
• InjuryJun 30, 2022Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - THE SURGEON PERFORMED AN IRRIGATION AND DRAINAGE FOR INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 14880613 ↗
• InjuryMar 21, 2022Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY: THE PATIENT PRESENTED WITH A DRAINING, OPEN WOUND.

  Patient problems: Impaired Healing

  MAUDE report 13841002 ↗
• InjuryJan 31, 2022Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY: DUE TO INSTABILITY.

  Patient problems: Insufficient Information

  MAUDE report 13403708 ↗
• InjuryDec 23, 2021Unstable

  REVISION SURGERY: PATIENT WAS UNSTABLE.

  Patient problems: Insufficient Information

  MAUDE report 13079046 ↗
• InjuryJun 18, 2021Unstable

  REVISION SURGERY - DUE TO INSTABILITY FROM ORIGINAL CASE. SURGEON HAD TO CHANGE THE POLY.

  Patient problems: Failure of Implant

  MAUDE report 12029322 ↗
• InjurySep 23, 2019Material Rupture

  REVISION SURGERY - PATIENT FELL POST OPERATION AND RUPTURED HER EXTENSOR MECHANISM. SURGEON FIXED AND ALSO SWAPPED POLY FOR ONE SIZE THICKER.

  Patient problems: Fall

  MAUDE report 9105696 ↗
• InjuryMay 1, 2019Material Rupture

  SECOND REVISION SURGERY - DUE TO THE PATIENT RUPTURING HER EXTENSOR MECHANISM. THE SURGEON ALSO SWAPPED THE POLY DURING THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8569157 ↗
• InjuryMar 12, 2019Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - DUE TO THE PATIENT HAVING A POST-OP INFECTION. THE SURGEON PERFORMED A WASH OUT AND CHANGED THE POLY.

  Patient problems: Unspecified Infection

  MAUDE report 8414648 ↗
• InjuryJun 27, 2018Insufficient Device Problem Information

  REVISION SURGERY - DUE TO THE PATIENT HAVING AN INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 7643561 ↗
• InjuryMay 18, 2018Material Rupture

  SECOND REVISION SURGERY - DUE TO THE PATIENT RUPTURING THEIR PATELLA TENDON. DURING THE PROCEDURE, THE SURGEON SWAPPED THE POLY FOR SAME SIZE. THIS WAS A REVISION OF A REVISION SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7527038 ↗
• InjuryOct 3, 2017Appropriate Device Problem Term/Code Not Available

  SECOND REVISION SURGERY - DUE TO THE PATIENT HAVING RUPTURED HER PATELLA TENDON. SHE HAD BEEN REVISED 2 DAYS PRIOR BY THE SURGEON DUE TO A POST-OP FALL. HE WENT BACK INTO FIX THAT ISSUE. WHEN HE DID HE ALSO SWAPPED THE POLY FOR A LARGER SIZE.

  Patient problems: Fall; Rupture

  MAUDE report 6912135 ↗
• InjuryJul 27, 2016Insufficient Device Problem Information

  REVISION SURGERY - DUE TO THE PATIENT HAVING AN INFECTION POST OPERATION. THE SURGEON WASHED OUT THE PATIENT AND REPLACED POLY WITH THE SAME SIZE.

  Patient problems: Unspecified Infection

  MAUDE report 5826046 ↗

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.