Fitmore® 01.00551.305Recalls & reported problems
Zimmer GmbH · Class 2 · Implant
All models of Fitmore (19)
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 00889024591684), received between Aug 24, 2021 and Aug 24, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Fracture” (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
- Fracture1
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Bone Fracture(s)1
- Limb Fracture1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 24, 2021Fracture; Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
PATIENT WAS IMPLANTED ON THE RIGHT SIDE AND WAS OPERATED ON (B)(6) 2021 TO CORRECT THE PERIPROSTHETIC FRACTURE DURING WHICH THE POLY LINER WAS REVISED. ANY KIND OF TRAUMA HAS NOT BEEN REPORTED.
Patient problems: Bone Fracture(s); Limb Fracture
MAUDE report 12358531 ↗
Other Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented devices
- NA 1365-51-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented753 reports
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- 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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