DJO SURGICAL 430-98-052Recalls & reported problems
Encore Medical, L.P. · FMP Hemispherical Shells w/Screw Holes, 52mm, w/P2 Coating · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DJO Surgical hip shell is an uncemented cup used in hip replacement. Reports mostly describe dislocations and pain with repeat surgery, with some mentioning loose cups or screws not locking in place. There are 23 reports, with no deaths and 23 injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 23
- Deaths reported
- 0
- Injuries reported
- 23
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00888912084024), received between Jan 20, 2017 and Aug 6, 2025 — classified as 23 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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 Problem7
- Appropriate Device Problem Term/Code Not Available6
- Device Dislodged or Dislocated4
- Loose or Intermittent Connection2
- Malposition of Device2
- Fracture1
- Incorrect, Inadequate or Imprecise Result or Readings1
- Insufficient Device Problem Information1
Patient problems
- Joint Dislocation5
- No Code Available4
- No Known Impact Or Consequence To Patient4
- Insufficient Information3
- Pain3
- Fall2
- Discomfort1
- Foreign Body In Patient1
Recent adverse event reports
The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.
InjuryAug 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT PRESENTED WITH PAIN DUE TO PSOAS TENDON IMPINGEMENT.
Patient problems: Pain
MAUDE report 18204850 ↗InjuryOct 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 26, 2022No Apparent Adverse Event; No Apparent Adverse Event
PRIMARY SURGERY - AFTER DRILLING THROUGH CUP HOLE TO PLACE SCREW, THE 5.0 SCREW DIDN'T LOCK INTO CUP AND WENT PAST CUP.
Patient problems: Foreign Body In Patient
MAUDE report 15674896 ↗InjuryMay 25, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - SURGEON REVISED CUP AND LINER ON THE CASE. PATIENT COMPLAINED OF PAIN.
Patient problems: Pain
MAUDE report 14498094 ↗InjuryMay 16, 2022Loose or Intermittent Connection
REVISION SURGERY - LOOSE CUP FLEXION, ONE SCREW. CUP PIVOT ON SCREW TO VERTICAL POSITION WITH FIBROUS IN GROWTH.
Patient problems: Insufficient Information
MAUDE report 14408430 ↗InjuryMar 4, 2022Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY : DUE TO CUP WAS TOO ANTEVERTED, HIP WAS DISLOCATING. REMOVED AND EXCHANGED OUT THE CUP, LINER, HEAD, AND SCREWS.
Patient problems: Insufficient Information
MAUDE report 13667772 ↗InjuryDec 2, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT'S CUP HAD MOVED AFTER A FALL AND NEEDED TO BE REPOSITIONED.
Patient problems: Fall
MAUDE report 12917770 ↗InjurySep 9, 2021Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT FELL AND HAD A DISLOCATION, SURGEON REPOSITIONED CUP WITH A DIFFERENT PRODUCT.
Patient problems: Fall; Joint Dislocation
MAUDE report 12448870 ↗InjuryJul 21, 2021Adverse Event Without Identified Device or Use Problem
InjuryJul 14, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - CONSTRAINED LINER FAILED DUE TO RETROVERTED CUP. SURGEON PULLED CUP, AND A STYKER CUP AND LINER WERE IMPLANTED. A NEW DJO HEAD WAS USED AS WELL.
Patient problems: Insufficient Information
MAUDE report 12170146 ↗InjuryJun 23, 2020Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - ACETABULAR CUP BECAME LOOSE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10184967 ↗InjuryMar 27, 2019Migration or Expulsion of Device; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO THE CUP MIGRATING SUPERIORLY. SPECIMEN WAS SENT TO PATHOLOGY CAGE WAS NEEDED FOR REVISION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8458225 ↗InjuryMar 15, 2019Fracture
REVISION SURGERY - DUE TO AN ACETABULAR FRACTURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8424784 ↗InjuryJan 15, 2019Unstable
REVISION SURGERY - REVISED FOR INSTABILITY. THE SURGEON BELIEVED THE CUP COMPONENT SPUN AFTER THE INITIAL SURGERY.
Patient problems: No Code Available
MAUDE report 8250307 ↗InjuryDec 12, 2018Malposition of Device; Material Protrusion/Extrusion
REVISION SURGERY - DUE TO THE CUP HAVING SHIFTED, THE SURGEON NEEDED TO REPLACE CAGE DUE TO PROTRUSIO (PROTRUSION).
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8158511 ↗InjuryJul 27, 2018Device Dislodged or Dislocated
REVISION SURGERY - DUE TO THE PATIENT HAVING DISLOCATED POST-OPERATIVE.
Patient problems: No Code Available
MAUDE report 7728775 ↗InjuryJun 13, 2018Incorrect, Inadequate or Imprecise Result or Readings; Insufficient Device Problem Information
REVISION SURGERY - DUE TO THE PATIENT COMPLAINING OF PAIN.
Patient problems: Pain
MAUDE report 7597415 ↗InjuryMar 22, 2018Device Dislodged or Dislocated
REVISION SURGERY - DUE TO A DISLOCATION. THE SURGEON ONLY REPLACED A DJO HEAD AND THE OTHER IMPLANTS WERE REPLACED WITH A COMPETITOR PART.
Patient problems: Joint Dislocation
MAUDE report 7362724 ↗InjuryFeb 23, 2018Device Dislodged or Dislocated
REVISION SURGERY - DUE TO SUPERIOR DISLOCATION, NOT CAUSED BY IMPLANTS. REVISION CUP PLACED SLIGHTLY MORE ANTERIOR.
Patient problems: No Code Available
MAUDE report 7293155 ↗InjuryJan 20, 2017Malposition of Device
REVISION SURGERY - DUE TO THE CUP PUSHING ON THE PATIENT'S BLADDER.
Patient problems: No Code Available
MAUDE report 6266685 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page