DJO SURGICAL 430-98-050Recalls & reported problems
Encore Medical, L.P. · FMP Hemispherical Shells w/Screw Holes, 50mm, w/P2 Coating · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 21
- Deaths reported
- 0
- Injuries reported
- 21
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00888912084017), received between Apr 5, 2016 and Feb 5, 2026 — classified as 21 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 Problem9
- Device Dislodged or Dislocated4
- Appropriate Device Problem Term/Code Not Available3
- Unstable3
- Insufficient Device Problem Information2
- Loosening of Implant Not Related to Bone-Ingrowth2
- Malposition of Device2
- Loose or Intermittent Connection1
Patient problems
- Implant Pain4
- No Code Available4
- Failure of Implant2
- Insufficient Information2
- Joint Dislocation2
- Joint Laxity2
- Pain2
- Fall1
Recent adverse event reports
The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.
InjuryFeb 5, 2026Device Dislodged or Dislocated
InjuryApr 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMar 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PATIENT WAS EXPERIENCING PAIN. SURGEON SUSPECTED INFECTION.
Patient problems: Implant Pain; Unspecified Infection
MAUDE report 21735600 ↗InjuryJan 16, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryAug 22, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryNov 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryApr 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjurySep 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - REPRESENTATIVE WAS CONTACTED FOR DJO FEMORAL HEADS. NO INFORMATION WAS PROVIDED REGARDING SURGICAL PLAN, OTHER THAN EXISTING CUP WILL BE REMOVED AND REPLACED WITH A CUP FROM A DIFFERENT VENDOR. REPRESENTATIVE WAS NOT PRESENT DURING REVISION SURGERY, AND RECEIVED INFORMATION AFTER SURGERY INCLUDING PATIENT STICKER, AND IMPLANT STICKERS (DELTA OPTION CERAMIC HEAD AND TI SLEEVE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15341450 ↗InjuryJul 13, 2022Malposition of Device
REVISION SURGERY - CUP IMPROPERLY PLACED DUE TO MALFORMATION OF THE PELVIS. CUP WAS PLACED TOO HIGH BY PREVIOUS SURGEON.
Patient problems: Insufficient Information
MAUDE report 15001895 ↗InjuryFeb 23, 2022Loosening of Implant Not Related to Bone-Ingrowth
REVISION SURGERY - CUP BECAME LOOSE AND SPUN OUT, BREAKING THE SCREWS. THE HEAD ENDED UP RUBBING A HOLE IN THE LINER AND CUP.
Patient problems: Failure of Implant
MAUDE report 13584450 ↗InjuryOct 12, 2021Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO DISLOCATION.
Patient problems: Insufficient Information
MAUDE report 12618984 ↗InjuryNov 8, 2019Loosening of Implant Not Related to Bone-Ingrowth
InjuryApr 4, 2019Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO A DISLOCATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8483871 ↗InjuryJan 14, 2019Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - THE PATIENT HAD IMPINGEMENT SUPERIORITY AND PAIN. THE X-RAYS LOOKED FINE, ALL COMPONENTS WERE WELL SEATED AND WERE NOT LOOSE AT THE TIME OF THE REVISION. THE SURGEON CHOSE TO EXPLANT THE ACETABULAR CUP, POLY, AND SCREW, AND REVISE TO A BIOMET G7 DUAL MOBILITY.
Patient problems: Pain
MAUDE report 8245631 ↗InjuryNov 1, 2018Unstable
REVISION SURGERY - DUE TO THE CUP GOING THROUGH THE MEDIAL WALL POST OPERATIVELY AND BECOMING UNSTABLE. THE SURGEON REMOVED AND REPLACED THE CUP AND LINER WITH COMPETITOR PRODUCTS. THE SURGEON ALSO REMOVED AND REPLACED THE HEAD AND ADDED A SLEEVE WITH A DJO PRODUCT. THE ORIGINAL STEM REMAINED IN THE PATIENT.
Patient problems: No Code Available
MAUDE report 8030517 ↗InjuryMar 6, 2018Appropriate Device Problem Term/Code Not Available
SECOND REVISION SURGERY - DUE TO THE PATIENT HAVING INSTABILITY. THE SURGEON PUT IN A DIFFERENT VENDOR SHELL AND LINER.
Patient problems: Failure of Implant
MAUDE report 7317741 ↗InjuryJun 16, 2017Loose or Intermittent Connection; Device Dislodged or Dislocated
REVISION SURGERY - DUE TO THE PATIENT HAVING A LOOSE CUP; THE HIP WAS DISLOCATING. A DJO 50MM CUP WITH 1 SCREW WAS REMOVED, A 56MM DJO P2 CUP WAS IMPLANTED WITH 3 SCREWS, 40 MM LINER AND HEAD WERE USED FOR STABILITY. NOT A PRODUCT PROBLEM.
Patient problems: No Code Available
MAUDE report 6648719 ↗InjuryFeb 21, 2017Insufficient Device Problem Information
REVISION SURGERY - THE COMPONENTS HAD TO BE REVISED BECAUSE THE PATIENT COMPLAINED OF FEMORAL NERVE PAIN.
Patient problems: Pain
MAUDE report 6346798 ↗InjuryOct 4, 2016Insufficient Device Problem Information
REVISION SURGERY - DUE TO THE PATIENT FALLING AND PUSHING THE SHELL THROUGH THE ACETABULUM.
Patient problems: Fall
MAUDE report 5998012 ↗InjuryApr 5, 2016Malposition of Device
REVISION SURGERY: DUE TO THE FMP CUP MOVING FROM THE ORIGINAL POSITION; THE SURGEON NEEDED TO REPLACE THE IMPLANT AND REPOSITION IT IN A BETTER LOCATION.
Patient problems: No Code Available
MAUDE report 5547520 ↗
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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