Fitmore® 01.00551.203Recalls & 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
- 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 00889024591578), received between Nov 19, 2021 and May 20, 2024 — classified as 2 injuries.
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.
Reports received per month
Most reported problems
Device problems
- Fracture1
- Material Erosion1
- Off-Label Use1
- Peeled/Delaminated1
- Separation Failure1
Patient problems
- Bone Fracture(s)2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Metal Related Pathology1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 20, 2024Peeled/Delaminated; Separation Failure; Peeled/Delaminated; Separation Failure
DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bone Fracture(s)
MAUDE report 19354023 ↗InjuryNov 19, 2021Material Erosion; Fracture; Off-Label Use; Material Erosion; Fracture; Off-Label Use
CORRECTION OF THE EVENT: IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED A BILATERAL THP. SEVEN YEARS LATER, THE PATIENT FELL FROM A BICYCLE, THAT HAD CAUSED THE FRACTURE OF THE LEFT FEMUR. THE PATIENT UNDERWENT A TOTAL REVISION OF THE LEFT HIP, FOLLOWING THE REVISION OF THE PROSTHESIS, BLOOD TESTS REVEALED ELEVATED LEVELS OF IONS. TWO COMPLAINTS WERE OPENED, AS LEFT AND RIGHT HIP PRODUCTS ARE INVOLVED: (B)(4) (PRESENT COMPLAINT) TREATS THE PATIENT'S RIGHT HIP; ELEVATED ION LEVELS. (B)(4), MFR 0009613350-2021-00588, TREATS THE PATIENT'S LEFT HIP; BICYCLE FALL WHICH FRACTURED FEMUR WITH SUBSEQUENT ELEVATED ION LEVELS.
Patient problems: Bone Fracture(s); Metal Related Pathology
MAUDE report 12842103 ↗
Other Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented devices
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- 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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