DJO SURGICAL 233-02-106Recalls & reported problems
Encore Medical, L.P. · FEMUR, NONPOROUS, 3D, SIZE6, RT · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888912111232), received between Aug 24, 2016 and Aug 15, 2018 — classified as 4 injuries.
The most frequently reported specific device problem is “Loose or Intermittent Connection” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Loose or Intermittent Connection2
- Unstable2
- Insufficient Device Problem Information1
- Naturally Worn1
Patient problems
- No Code Available2
- Failure of Implant1
- Pain1
- Unspecified Infection1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryAug 15, 2018Loose or Intermittent Connection; Unstable
REVISION SURGERY - DUE TO PAIN AND INSTABILITY JOINT. THE INITIAL SURGERY THE IMPLANTS WERE OVERSIZE AND LOOSE. THE SIZE 6 FEMUR AND 4 TIBIA WERE TAKEN OUT AND REVISED WITH A SIZE 4.
Patient problems: Pain
MAUDE report 7786890 ↗InjuryAug 3, 2018Loose or Intermittent Connection; Naturally Worn
REVISION SURGERY - DUE TO THE PATIENT BEING LOOSE. THE SURGEON FOUND THAT THE FEMUS WAS LOOSE AND THE POLY WAS WORN OUT. THE ORIGINAL IMPLANTS WERE REMOVED AND REPLACED.
Patient problems: Failure of Implant; No Code Available
MAUDE report 7748759 ↗InjuryJan 26, 2018Unstable
REVISION SURGERY - DUE TO THE PATIENT HAVING INSTABILITY.
Patient problems: No Code Available
MAUDE report 7222731 ↗InjuryAug 24, 2016Insufficient Device Problem Information
REVISION SURGERY - DUE TO THE PATIENT'S KNEE HAVING BECOME INFECTED SEVERAL YEARS FOLLOWING A TOTAL KNEE ARTHROPLASTY (TKA). THE SURGEON REMOVED ALL OF THE COMPONENTS AND CEMENTED IN AN ARTICULATING BEARING SPACER WITH ANTI-BIOTIC CEMENT.
Patient problems: Unspecified Infection
MAUDE report 5901511 ↗
Other PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER devices
- ATTUNE 1512-14-050Depuy (Ireland) · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER106 reports
- ATTUNE 1504-40-205Depuy (Ireland) · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall53 reports
- ATTUNE 1504-40-105Depuy (Ireland) · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall46 reports
- ATTUNE 1547-06-001Depuy (Ireland) · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall37 reports
- ATTUNE 1513-12-060Depuy (Ireland) · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER72 reports
- Triathlon 5521-B-300Howmedica Osteonics Corp. · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall19 reports
- Triathlon 5531-G-709-EHowmedica Osteonics Corp. · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall19 reports
- ATTUNE 1512-16-080Depuy (Ireland) · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall16 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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page