Restoration 504-02-54C-RRecalls & reported problems
Howmedica Osteonics Corp. · Anatomic Hemispherical Shell · Class 2 · Implant
All models of Restoration (86)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327012415), received between Jun 27, 2019 and Jul 2, 2019 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Component Misassembled” (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.
Most reported problems
Device problems
- Component Misassembled4
- Packaging Problem4
Patient problems
- No Consequences Or Impact To Patient3
- No Known Impact Or Consequence To Patient3
- No Patient Involvement1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 2, 2019Packaging Problem; Component Misassembled; Packaging Problem; Component Misassembled
UPON INCOMING INSPECTION IT WAS NOTICED THAT THE IMPLANT WAS LOOSE IN PACKAGING.
Patient problems: No Patient Involvement
MAUDE report 8752358 ↗MalfunctionJul 1, 2019Packaging Problem; Component Misassembled; Packaging Problem; Component Misassembled
UPON INCOMING INSPECTION IT WAS NOTICED THAT THE IMPLANTS WERE LOOSE IN PACKAGING. IMPLANTS HAVE BEEN SHIPPED TO THE (B)(6). NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 8748312 ↗MalfunctionJun 27, 2019Packaging Problem; Component Misassembled; Packaging Problem; Component Misassembled
UPON INCOMING INSPECTION IT WAS NOTICED THAT THE IMPLANTS WERE LOOSE IN PACKAGING. THE IMPLANTS HAVE BEEN SHIPPED TO THE DECON LAB. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 8738763 ↗MalfunctionJun 27, 2019Packaging Problem; Component Misassembled; Packaging Problem; Component Misassembled
UPON INCOMING INSPECTION IT WAS NOTICED THAT THE IMPLANT WAS LOOSE IN PACKAGING. IMPLANTS HAVE BEEN SHIPPED TO THE DECON LAB. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 8738761 ↗
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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