Restoration 2082-0056RRecalls & reported problems
Howmedica Osteonics Corp. · Acetabular Shell · Class 2 · Implant
All models of Restoration (86)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327017571), received between May 26, 2023 and May 26, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (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
- Break1
- Fracture1
- Loss of Osseointegration1
Patient problems
- Ambulation or Postural Difficulties1
- Bone Fracture(s)1
- Fall1
- Inadequate Osseointegration1
- Insufficient Information1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 26, 2023Break; Fracture; Loss of Osseointegration; Break; Fracture; Loss of Osseointegration
THIS PI FOR REVISION. SON OF PATIENT STATED HIS MOTHER HAD PRIMARY RIGHT HIP SURGERY ON (B)(6) 2022. ON (B)(6) 2022 PATIENT EXPERIENCED INCREASE PAIN AND X-RAYS CONFIRMED A 1/2 INCH WIDE BREAK. IT WAS ALSO STATED THAT ON (B)(6) 2022 A "CAGE WAS ADDED" DUE TO HER IMPLANT "POPPING OUT" TWICE. SON DID NOT CONFIRM WHAT WAS POPPING OUT. A REVISION WAS THEN PERFORMED ON (B)(6) 2023; "HEAD AND CUP" WERE REPLACED WITH COMPETITOR PRODUCTS. UPDATE: ON (B)(6) 2023 THE PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING OF THE ACETABULAR COMPONENT AND ACETABULAR BONE LOSS RESULTING IN PELVIC DISCONTINUITY WHEREBY ALL COMPONENTS WERE EXPLANTED AND A CUSTOM TRI-FLANGE COMPETITOR CONSTRUCT WAS IMPLANTED.
Patient problems: Ambulation or Postural Difficulties; Bone Fracture(s); Fall; Inadequate Osseointegration; Insufficient Information; Pain
MAUDE report 17008993 ↗
Other Prosthesis, hip, semi-constrained, metal/polymer, cemented devices
- NA 1365-51-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented753 reports
- NA 1365-50-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented412 reports
- ARTICUL/EZE 1365-21-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall280 reports
- ARTICUL/EZE 1365-11-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 death262 reports
- LFIT 6260-9-236Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, cemented256 reports
- PINNACLE GRIPTION 1217-32-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented2 deaths239 reports
- ELEOS™ 25002111EOnkos Surgical, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented3 deaths230 reports
- Novation 130-36-52Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2 recalls124 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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