Restoration 1235-2-561Recalls & reported problems
Howmedica Osteonics Corp. · ADM- Cup w/HA · Class 2 · Implant
All models of Restoration (86)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540638786), received between Sep 23, 2020 and Dec 12, 2022 — classified as 2 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Insufficient Device Problem Information1
- Malposition of Device1
Patient problems
- Bursitis1
- Insufficient Information1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 12, 2022Malposition of Device; Adverse Event Without Identified Device or Use Problem; Malposition of Device; Adverse Event Without Identified Device or Use Problem
THE FOLLOWING WAS REPORTED: TOTAL HIP REPLACEMENT ON (B)(6) 2013 THEN SUBJECT REPORTS PAIN AT OPERATIVE SITE IN ON (B)(6) 2022. DIAGNOSED WITH TROCHANTERIC BURSITIS AND TREATED WITH LOCAL INFILTRATION BUCAINE AND LIPOTALONE. THE BURSITIS IS CONSIDERED RELATED TO THE SURGICAL PROCEDURE.
Patient problems: Bursitis; Pain
MAUDE report 15957033 ↗InjurySep 23, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
AS REPORTED: PATIENT HAD HIS RIGHT HIP REVISED. THE REJUVENATE MODULAR STEM AND NECK WERE REMOVED AND REPLACED BY A RESTORATION MODULAR STEM. SURGEON ALSO REPLACED THE ADM ACETABULAR CUP WITH A TRITANIUM REVISION SHELL. PATIENT'S CHROMIUM LEVEL WAS LESS THAN 1.0 AND HIS COBALT LEVEL WAS LESS THAN 0.5
Patient problems: Insufficient Information
MAUDE report 10572430 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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