FitmoreRecalls & reported problems across all models
Zimmer GmbH · 19 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 25
- Deaths reported
- 0
- Injuries reported
- 23
- Recalls
- 0
We found 19 models of Fitmore by Zimmer GmbH in the FDA's device registry (GUDID). Together they are named in 25 adverse event reports in the FDA's MAUDE database, received between Jan 29, 2019 and Nov 28, 2025 — classified as 23 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (6 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Fitmore problems
Device problems
- Fracture6
- Adverse Event Without Identified Device or Use Problem5
- Loosening of Implant Not Related to Bone-Ingrowth4
- Insufficient Device Problem Information3
- Migration2
- Biocompatibility1
- Device Dislodged or Dislocated1
- Inadequacy of Device Shape and/or Size1
Patient problems
- Bone Fracture(s)9
- Pain7
- Failure of Implant5
- Metal Related Pathology3
- No Code Available2
- No Known Impact Or Consequence To Patient2
- Swelling/ Edema2
- Ambulation or Postural Difficulties1
Fitmore models
19 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Fitmore® 01.00551.205Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented3 reports
- Fitmore® 01.00551.303Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented2 reports
- Fitmore® 01.00551.307Prosthesis, hip, hemi-, femoral, metal2 reports
- Fitmore® 01.00551.203Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2 reports
- Fitmore® 01.00551.310Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2 reports
- Fitmore® 01.00551.110Prosthesis, hip, hemi-, femoral, metal1 report
- Fitmore® 01.00551.312Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- Fitmore® 01.00551.306Prosthesis, hip, hemi-, femoral, metal1 report
- Fitmore® 01.00551.206Prosthesis, hip, hemi-, femoral, metal1 report
- Fitmore® 01.00551.403Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- Fitmore® 01.00551.406Prosthesis, hip, constrained, cemented or uncemented, metal/polymer1 report
- Fitmore® 01.00551.202Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1 report
- Fitmore® 01.00551.304Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1 report
- Fitmore® 01.00551.305Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1 report
- Fitmore® 01.00551.206Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1 report
- Fitmore® 01.00551.404Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1 report
- Fitmore® 01.00551.207Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1 report
- Fitmore® 01.00551.112Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1 report
- Fitmore® 01.00551.210Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1 report
Recent Fitmore adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryNov 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.
Patient problems: Pain; Unequal Limb Length
MAUDE report 23669786 ↗InjuryMay 21, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THE PATIENT UNDERWENT A STEM REVISION APPROXIMATELY 10 MONTHS POST IMPLANTATION; THE STEM REVISION WAS DUE TO MOBILIZATION AFTER AN ACCIDENT. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.
Patient problems: Aseptic loosening; Failure of Implant
MAUDE report 22061359 ↗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 ↗InjuryMay 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A PATIENT HAD AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, APPROXIMATELY 9 YEARS POST IMPLANTATION, EXPERIENCED A PERIPROSTHETIC FEMORAL FRACTURE AND UNDERWENT INTERNAL FIXATION WITH A PLATE AND CABLE WIRES. DILIGENCE IS COMPLETED AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Bone Fracture(s)
MAUDE report 19351317 ↗InjuryMar 27, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Bone Fracture(s); Failure of Implant; Fall
MAUDE report 18989053 ↗InjuryOct 25, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant
MAUDE report 18004700 ↗InjuryDec 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED IN A CLINICAL STUDY THAT A PATIENT EXPERIENCED A PERIPROSTHETIC FRACTURE OF THE TIP OF THE GREATER TROCHANTER. THE LINE OF THE FRACTURE DID NOT TOUCH THE STEM. PAINKILLERS WAS THE ONLY TREATMENT GIVEN. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.
Patient problems: Bone Fracture(s); Pain
MAUDE report 15968819 ↗InjuryNov 19, 2021Fracture; Unstable; Fracture; Unstable
IT WAS REPORTED THAT THE PATIENT WAS FELL FROM A BICYCLE, THAT HAD CAUSED THE FRACTURE OF THE FEMUR. THE PATIENT UNDERWENT A TOTAL REVISION OF THE LEFT HIP, FOLLOWING THE REVISION OF THE PROSTHESIS, BLOOD TESTS REVEALED ELEVATED LEVELS OF IONS.
Patient problems: Bone Fracture(s); Metal Related Pathology
MAUDE report 12847032 ↗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 ↗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 ↗InjuryJul 5, 2021Biocompatibility; Patient Device Interaction Problem; Biocompatibility; Patient Device Interaction Problem
NO CHANGE TO PREVIOUSLY REPORTED EVENT.
Patient problems: Metal Related Pathology; Swelling/ Edema
MAUDE report 12116269 ↗InjuryJan 13, 2021Patient-Device Incompatibility; Patient-Device Incompatibility
PATIENT WAS IMPLANTED ON THE LEFT SIDE AND DURING IMPLANTATION OF THE FITMORE STEM A FISSURE(CRACK) OCCURRED ON THE FEMUR. WHEN THE STEM(SIZE: A10) SUNK TOO LOW AFTER RASPING THE FEMUR. ANOTHER STEM OF LARGER SIZE (SIZE: A12) WAS USED, WHICH ALSO HAD THE SAME ISSUE. RADIOGRAPHY REVEALED A PROXIMAL FEMUR FRACTURE LATERALLY. THERE WAS A SURGICAL DELAY OF 45 MIN.
Patient problems: Bone Fracture(s)
MAUDE report 11162733 ↗InjuryDec 28, 2020Loose or Intermittent Connection; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS IMPLANTED ON LEFT SIDE AND AT THE SEVEN-YEAR VISIT THE PATIENT WAS DIAGNOSED WITH SUPRA ACETABULAR CAVITY OSTEOLYSIS. CT SCAN AND EVALUATION OF INFLAMMATION FROM ESR AND CRP DONE. SERUM TITANIUM LEVELS AND A JOINT ASPIRATION TO OBTAIN SAMPLES FOR CULTURES, CELL COUNT AND METAL ION LEVELS TO BE PERFORMED.
Patient problems: Osteolysis; Swelling/ Edema
MAUDE report 11077371 ↗InjuryJun 10, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
InjuryMar 16, 2020Fracture; Migration; Fracture; Migration
PATIENT WAS IMPLANTED ON THE RIGHT SIDE AND UNDERWENT REVISION DUE TO PERIPROSTHETIC FRACTURE.
Patient problems: Bone Fracture(s); No Known Impact Or Consequence To Patient
MAUDE report 9835413 ↗
Other Zimmer GmbH products
- Affixus Natural Nail55 models · 612 reports
- Biolox delta16 models · 343 reports
- NCB78 models · 200 reports
- Zimmer Natural Nail System57 models · 187 reports
- Biolox Option16 models · 68 reports · 2 recalls
- Avenir24 models · 57 reports · 1 recall
- Anatomical Shoulder33 models · 102 reports
- Sidus Stem-Free Shoulder9 models · 30 reports · 1 recall
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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