DJO SURGICAL 315-0C-712Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00888912114080), received between Jul 7, 2017 and Jul 11, 2024 — classified as 8 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJul 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO PAIN.

  Patient problems: Implant Pain

  MAUDE report 19726866 ↗
• InjuryApr 19, 2024Unstable; 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 19149681 ↗
• InjuryMay 9, 2023Adverse 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 16900128 ↗
• InjurySep 7, 2021Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 12432824 ↗
• InjuryApr 3, 2020Appropriate Device Problem Term/Code Not Available

  SECOND REVISION SURGERY - PATIENT DEVELOPED A LARGE HEMATOMA SO SURGEON DID A WASHOUT AND CHANGED POLY.

  Patient problems: Hematoma

  MAUDE report 9921022 ↗
• InjuryAug 8, 2019Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - PATIENT WAS REVISED DUE TO A WOUND DEHISCENCE THAT POSSIBLY TRACKED TO THE JOINT. IRRIGATION AND DRAINAGE WAS PERFORMED WITH ANTIBIOTICS AND A POLY EXCHANGE.

  Patient problems: Wound Dehiscence

  MAUDE report 8875273 ↗
• InjuryMay 25, 2018Stretched; Device Dislodged or Dislocated

  REVISION SURGERY - DUE TO THE PATIENT HAVING DISLOCATED AND HAVING STRETCHED OUT. THE SURGEON PUT IN A 17 MILLIMETER INSERT.

  Patient problems: No Code Available

  MAUDE report 7545982 ↗
• InjuryJul 7, 2017Insufficient Device Problem Information

  REVISION SURGERY - DUE TO THE PATIENT HAVING A POST OP INFECTION; THE SURGEON WASHED THEM OUT AND SWAPPED THE POLY AS WELL.

  Patient problems: Unspecified Infection

  MAUDE report 6695329 ↗

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.