DJO SURGICAL 430-98-048Recalls & reported problems
Encore Medical, L.P. · FMP Hemispherical Shells w/Screw Holes, 48mm, w/P2 Coating · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888912084000), received between Jan 12, 2017 and Oct 29, 2019 — classified as 6 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available3
- Device Dislodged or Dislocated2
- Loose or Intermittent Connection1
- Unstable1
Patient problems
- No Known Impact Or Consequence To Patient3
- Pain2
- No Code Available1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryOct 29, 2019Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT PRESENTED PAIN TO THE SURGEON. LYSIS BEHIND THE SHELL/ POOR BONE GROWTH.
Patient problems: Pain
MAUDE report 9249624 ↗InjuryOct 3, 2019Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO ACETABULAR CUP LOOSENING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9150838 ↗InjurySep 4, 2019Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - CUP WAS NEVER SEATED ON ORIGINAL SURGERY, DID NOT INGROW. PRESENTED WITH PAIN POST OPERATION. ACETABULAR COMPONENTS WERE REMOVED, LARGER SIZE IMPLANTED.
Patient problems: Pain
MAUDE report 8962491 ↗InjuryMar 23, 2018Unstable
REVISION SURGERY - DUE TO THE PATIENT'S HIP BEING UNSTABLE. THE SURGEON REMOVED AND REPLACED THE ORIGINAL SHELL, LINER, AND HEAD.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7367348 ↗InjuryDec 7, 2017Device Dislodged or Dislocated
REVISION SURGERY - THE SHELL, LINER AND HEAD WERE REMOVED FROM THE PATIENT. THE ITEMS WERE REMOVED BECAUSE THE PATIENT KEPT DISLOCATING DUE TO RETROVERSION OF THE CUP AND THE ANATOMY OF THE PATIENT (PATIENT LUMBAR SPINE WAS FUSED). DUAL MOBILITY WAS PUT IN AND ANTROVERTED. THE SURGEON REPLACED THE CUP AND LINER WITH A COMPETITOR'S PRODUCT.
Patient problems: No Code Available
MAUDE report 7095522 ↗InjuryJan 12, 2017Device Dislodged or Dislocated
REVISION SURGERY - DUE TO THE IMPLANTATION OF THE ACETABULAR CUP HAVING TOO MUCH INCLINATION; THE PATIENT WAS DISLOCATING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6247256 ↗
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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