DJO SURGICAL 431-32-707Recalls & reported problems
Encore Medical, L.P. · FMP NEUTRAL LINER, 32MM, MP7, HXE-PLUS · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888912084635), received between Apr 16, 2019 and Feb 17, 2022 — classified as 6 injuries.
The most frequently reported specific device problem is “Fracture” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available3
- Adverse Event Without Identified Device or Use Problem2
- Fracture1
- Microbial Contamination of Device1
Patient problems
- Unspecified Infection4
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryFeb 17, 2022Appropriate Device Problem Term/Code Not Available
InjurySep 1, 2021Microbial Contamination of Device; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY: DUE TO PERIPROSTHETIC INFECTION.
Patient problems: Unspecified Infection
MAUDE report 12407407 ↗InjurySep 13, 2019Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO UNKNOWN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 9050339 ↗InjuryAug 2, 2019Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO POSSIBLE INFECTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8855307 ↗InjuryMay 29, 2019Fracture
REVISION SURGERY - DUE TO A PERIPROSTHETIC FRACTURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8650019 ↗InjuryApr 16, 2019Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO THE PATIENT HAVING AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 8519154 ↗
Other Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented devices
- PINNACLE 1217-25-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED735 reports
- NA 1365-52-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED683 reports
- APEX 1246-03-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED3 deaths613 reports
- PINNACLE 1217-20-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 deaths590 reports
- PINNACLE 1217-30-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 death484 reports
- NA 1365-53-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED404 reports
- PINNACLE ALTRX 1221-36-054Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED388 reports
- PINNACLE ALTRX 1221-32-050Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED386 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 16, 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