Restoration 504-02-58D-LRecalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327012385), received between Jun 20, 2019 and May 29, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Packaging Problem” (1 report).
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 Problem1
- Packaging Problem1
Patient problems
- Bone Fracture(s)1
- No Consequences Or Impact To Patient1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE FOLLOWING WAS REPORTED: "CEMENTED CONSTRAINED CUP DISLOCATED FOLLOWING MOVEMENT IN PATIENTS BED. CEMENTED CONSTRAINED CUP REMOVED AND REPLACED WITH A RAS SHELL, WHEN IMPACTING THE 58MM RAS SHELL THE SURGEON THEN HAD A FRACTURE IN THE MEDIAL WALL SO SHELL WAS UPSIZED TO 62MM. LEFT HIP". UPDATE: THE INNER BIPOLAR COMPONENT DISLOCATED FROM THE OUTER COMPONENT.
Patient problems: Bone Fracture(s)
MAUDE report 19420000 ↗MalfunctionJun 20, 2019Packaging Problem; Packaging Problem
UPON INCOMING INSPECTION IT WAS NOTICED THAT THE DEVICE WAS LOOSE IN PACKAGING.
Patient problems: No Consequences Or Impact To Patient; No Patient Involvement
MAUDE report 8716035 ↗
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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