DJO SURGICAL 430-98-054Recalls & reported problems
Encore Medical, L.P. · FMP Hemispherical Shells w/Screw Holes, 54mm, w/P2 Coating · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00888912084031), received between Apr 14, 2016 and Jan 27, 2025 — classified as 10 injuries, 1 malfunction.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem4
- Appropriate Device Problem Term/Code Not Available3
- Loose or Intermittent Connection2
- Device Dislodged or Dislocated1
- Device Operates Differently Than Expected1
- Inadequacy of Device Shape and/or Size1
- Migration or Expulsion of Device1
- Positioning Problem1
Patient problems
- No Code Available4
- Failure of Implant2
- Joint Dislocation2
- Pain2
- Unspecified Infection2
- Joint Laxity1
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
InjuryJan 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryDec 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJul 27, 2020Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT COMPLAINED OF HIP PAIN AFTER PRIMARY TOTAL HIP ARTHROPLASTY. POSSIBLE, BUT NOT IDENTIFIED CUP LOOSENING /MINIMAL BONY IN GROWTH. SURGEON REVISED CUP TO STRYLER TRIDENT 2 WITH MOM BEARING. REPLACED 36MM HEAD WITH DJO 28MM CERAMIC BIOLOX HEAD.
Patient problems: Pain
MAUDE report 10326033 ↗InjuryJul 31, 2019Inadequacy of Device Shape and/or Size; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - REVISION DUE TO LENGTH DISCREPANCY. REMOVED AND REPLACED THE ORIGINAL SHELL, LINER, SCREWS, HEAD AND SLEEVE.
Patient problems: Failure of Implant
MAUDE report 8846898 ↗InjuryJan 30, 2019Loose or Intermittent Connection; Positioning Problem
REVISION SURGERY - THE SURGEON REPLACED THE CUP, LINER AND HEAD DUE TO THE PATIENT'S HIP DISLOCATING.
Patient problems: Joint Dislocation
MAUDE report 8290280 ↗InjuryApr 6, 2018Device Operates Differently Than Expected; Unintended Movement
REVISION SURGERY - DUE TO THE INITIAL CUP HAVING RETROVERTED. THE SURGEON REMOVED THE COMPONENTS AND REPLACED WITH NEW IMPLANTS.
Patient problems: Failure of Implant; No Code Available
MAUDE report 7404871 ↗InjurySep 28, 2017Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PATIENT PRESENTED AT DOCTORS OFFICE COMPLAINING OF HIP PAIN. AFTER X-RAYS, SURGEON DECIDED TO REVISE THE ACETABULAR COMPONENT.
Patient problems: No Code Available; Pain
MAUDE report 6902208 ↗MalfunctionMay 1, 2017Migration or Expulsion of Device
REPORTED INCIDENT/COMPLAINT - THE SURGEON WAS PLACING A SCREW IN THE ACET CUP/SHELL AND THE SCREW WENT THROUGH THE CUP HOLE COMPLETELY. THE SCREW WAS "BACKED OUT" AND A NEW CUP WAS OPENED AND NEW SCREWS WERE PLACE IN NEW CUP.
Patient problems: No Code Available
MAUDE report 6535712 ↗InjuryDec 3, 2016Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO THE PATIENT'S HIP BEING INFECTED.
Patient problems: Unspecified Infection
MAUDE report 6143801 ↗InjuryApr 22, 2016Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO THE PATIENT DEVELOPING AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 5600023 ↗InjuryApr 14, 2016Device Dislodged or Dislocated
REVISION SURGERY - DUE TO CHRONIC DISLOCATION; THE CUP NEEDED TO BE ANTEVERTED FOR CORRECTION.
Patient problems: No Code Available
MAUDE report 5579746 ↗
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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