DJO SURGICAL 431-32-709Recalls & reported problems
Encore Medical, L.P. · FMP NEUTRAL LINER, 32MM, MP9, HXE-PLUS · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888912084659), received between Dec 27, 2017 and Jul 7, 2026 — classified as 5 injuries.
The most frequently reported specific device problem is “Device Slipped” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available1
- Device Slipped1
- Loose or Intermittent Connection1
- Patient Device Interaction Problem1
- Unstable1
Patient problems
- Failure of Implant2
- Unspecified Infection2
- Joint Laxity1
- Pain1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryJul 7, 2026Patient Device Interaction Problem
REVISION SURGERY DUE TO PAIN/INFECTION.
Patient problems: Pain; Unspecified Infection
MAUDE report 25742495 ↗InjuryMay 27, 2026Unstable
InjuryNov 12, 2019Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - ALL IMPLANTS REMOVED BECAUSE PATIENT HAD AN INFECTED HIP. NO DJO IMPLANTS WERE PLACED, SURGEON USED ANOTHER COMPANY.
Patient problems: Unspecified Infection
MAUDE report 9310738 ↗InjuryFeb 1, 2018Loose or Intermittent Connection
REVISION SURGERY - DUE TO LOOSENING COMPONENT.
Patient problems: Failure of Implant
MAUDE report 7234013 ↗InjuryDec 27, 2017Device Slipped
REVISION SURGERY - AFTER THE PRIMARY SURGERY, ON THE SAME DAY, THE CUP CAME LOOSE IN POST OPERATIVE AREA.
Patient problems: Failure of Implant
MAUDE report 7148626 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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