DJO SURGICAL 931-28-748Recalls & reported problems
Encore Medical, L.P. · LINER/NON-HOODED-NEU, MP5, HXe-plus, 28mm · 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 00888912099431), received between Jan 9, 2018 and Jan 18, 2022 — classified as 5 injuries.
The most frequently reported specific device problem is “Loose or Intermittent Connection” (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.
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available2
- Adverse Event Without Identified Device or Use Problem1
- Loose or Intermittent Connection1
- Malposition of Device1
- Patient-Device Incompatibility1
- Unstable1
Patient problems
- Unspecified Infection2
- Insufficient Information1
- No Information1
- Pain1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryJan 18, 2022Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO STEM LOOSENING.
Patient problems: Insufficient Information
MAUDE report 13284487 ↗InjuryJan 6, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY: PATIENT WAS INFECTED.
Patient problems: Unspecified Infection
MAUDE report 13173659 ↗InjuryFeb 18, 2020Adverse Event Without Identified Device or Use Problem
REVISION SURGERY: PATIENT HAD AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 9720007 ↗InjuryDec 23, 2019Patient-Device Incompatibility
SECOND REVISION SURGERY - PATIENT HAD PREVIOUS HIP REVISION SURGERY AND WAS STILL EXPERIENCING PAIN. SURGEON ELECTED TO REMOVE THE STEM THAT WAS IMPLANTED (NOT DJO) AND REVISE IT TO ANOTHER SYSTEM (NOT DJO). HE REQUESTED A NEW LINER WITH A LARGER HEAD OPTION. SO, WE REVISED THE LINER FROM 28MM DIAMETER TO 32MM OPTION.
Patient problems: Pain
MAUDE report 9511010 ↗InjuryJan 9, 2018Unstable; Malposition of Device
REVISION SURGERY - THE PATIENT WAS UNSTABLE DUE TO THE POSITION THE SURGEON PUT THE CUP IN.
Patient problems: No Information
MAUDE report 7175339 ↗
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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