DJO SURGICAL 430-98-058Recalls & reported problems
Encore Medical, L.P. · FMP Hemispherical Shells w/Screw Holes, 58mm, 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 00888912084062), received between Mar 9, 2016 and Aug 23, 2021 — classified as 6 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 Available2
- Insufficient Device Problem Information2
- Device Dislodged or Dislocated1
- Loose or Intermittent Connection1
Patient problems
- No Code Available2
- Pain2
- Failure of Implant1
- Insufficient Information1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryAug 23, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO UNKNOWN REASON.
Patient problems: Insufficient Information
MAUDE report 12356066 ↗InjurySep 20, 2019Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT WAS EXPERIENCING PAIN. POSSIBLE ILIOPSOAS IMPINGEMENT. REVISED THE CUP WITH ANOTHER VENDOR AND USED OUR HEAD AND SLEEVE ON OUR RETAINED STEM.
Patient problems: Pain
MAUDE report 9099478 ↗InjuryAug 8, 2019Loose or Intermittent Connection
REVISION SURGERY - THE SHELL HAD LOOSENED.
Patient problems: Failure of Implant
MAUDE report 8875736 ↗InjurySep 29, 2017Insufficient Device Problem Information
REVISION SURGERY - DUE TO PATIENT HAVING HIP PAIN, SO SURGEON REVISED HER CUP.
Patient problems: Pain
MAUDE report 6904825 ↗InjuryJan 6, 2017Device Dislodged or Dislocated
REVISION SURGERY - DUE TO THE PATIENT DISLOCATING WHILE IN RECOVERY. THE CUP WAS ANTEVERTED, WHICH THE SURGEON FELT WAS THE CAUSE OF THE DISLOCATION. HE WENT BACK IN AND WENT FROM A STANDARD OFFSET TO A LATERAL OFFSET STEM TO HELP AID WITH STABILITY.
Patient problems: No Code Available
MAUDE report 6229242 ↗InjuryMar 9, 2016Insufficient Device Problem Information
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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