Restoration 504-02-64E-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
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327012460), received between Jul 1, 2019 and May 26, 2020 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Component Misassembled” (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.
Most reported problems
Device problems
- Component Misassembled1
- Device Dislodged or Dislocated1
- Insufficient Device Problem Information1
- Packaging Problem1
Patient problems
- Injury2
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
- Unspecified Infection1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMay 26, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
ON UNKNOWN DATE, THE PATIENT EXPERIENCE INFECTION AFTER THA PROCEDURE. ON AN UNKNOWN DATE, REVISION SURGERY DUE TO INFECTION WAS PERFORMED.
Patient problems: Injury; Unspecified Infection
MAUDE report 10086302 ↗InjuryMay 19, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE PATIENT REPEATED DISLOCATION WHICH WAS PATIENT-INDUCED. THEN, THE PATIENT UNDERWENT REVISION SURGERY.
Patient problems: Injury
MAUDE report 10072615 ↗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 DECON LAB. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 8749142 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page