CitationRecalls & reported problems across all models
Howmedica Osteonics Corp. · 20 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 43
- Deaths reported
- 0
- Injuries reported
- 39
- Recalls
- 0
We found 20 models of Citation by Howmedica Osteonics Corp. in the FDA's device registry (GUDID). Together they are named in 43 adverse event reports in the FDA's MAUDE database, received between Sep 5, 2018 and Aug 31, 2026 — classified as 39 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Degraded” (15 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 Citation problems
Device problems
- Degraded15
- Insufficient Device Problem Information13
- Detachment of Device or Device Component8
- Material Erosion8
- Device Dislodged or Dislocated7
- Fracture7
- Corroded3
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Injury17
- Ambulation or Postural Difficulties13
- Metal Related Pathology9
- Pain8
- Foreign Body Reaction7
- Reaction7
- Inflammation6
- Bone Fracture(s)5
Citation models
20 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Citation 6265-5114PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED7 reports
- Citation 6265-5104Prosthesis, hip, semi-constrained, metal/polymer, cemented6 reports
- Citation 6265-5115Prosthesis, hip, semi-constrained, metal/polymer, uncemented5 reports
- Citation 6265-5103Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate3 reports
- Citation 6265-5116PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED3 reports
- Citation 6265-5105Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous2 reports
- Citation 6265-5113Prosthesis, hip, constrained, cemented or uncemented, metal/polymer2 reports
- Citation 6265-5117Prosthesis, hip, semi-constrained, metal/polymer, cemented2 reports
- Citation 6265-5213Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented2 reports
- Citation 6265-5102Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous1 report
- Citation 6265-5108Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish1 report
- Citation 6265-5112Prosthesis, hip, hemi-, femoral, metal1 report
- Citation 6265-5203Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate1 report
- Citation 6265-5204Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate1 report
- Citation 6265-5205Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- Citation 6265-5207Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- Citation 6265-5214Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate1 report
- Citation 6265-5216Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate1 report
- Citation 6265-5217Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- Citation 6265-5218Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
Recent Citation adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryAug 31, 2026Degraded
It was reported that the patient's Right hip was revised after patient complaint of pain. Intra-operatively, the following was reported: There was a moderate amount of black tissue removed. OR staff remarked that the liner appeared more yellow than expected. The stem, though well-fixed, had corrosion on the trunnion. The trunnion was cleaned off, and the well-fixed stem and shell remained in situ. Rep confirmed that no further information will be released by the hospital or surgeon.
Patient problems: Foreign Body Reaction; Pain
MAUDE report 50516764 ↗InjuryJun 29, 2026Degraded; Fracture
THE FOLLOWING INFORMATION WAS PROVIDED: PT. REPORTED; SHE HAD HER INITIAL HIP REPLACEMENT ON (B)(6) 2010. SHE EXPERIENCED A LOT OF PAIN AND IT STARTED TO DISLOCATE AFTER 11 YEARS. ON (B)(6) 2021, SHE HAD HER 1ST REVISION FOR DISLOCATION. A SECOND HIP REPLACEMENT WHICH WAS ALSO A STRYKER PRODUCT WAS IMPLANTED. SHE HAD COMPLAINTS ABOUT IT FROM THE MOMENT IT WAS PUT IN. IT JUST WASN'T COMFORTABLE IT DIDN'T FEEL RIGHT. THERE WAS A LOT OF PAIN FOR THREE YEARS AND SHE WAS TOLD EVERYTHING WAS FINE THERE WAS NOTHING WRONG WITH THE PRODUCT. ON (B)(6) 2025, SHE WENT FOR A SECOND OPINION AND IT WAS DISCOVERED THAT THE BALL WAS WEARING ON THE STEM CAUSING A RIDGE TO DEVELOP, THE SCREW WHICH HELD THE BALL WAS BROKEN, SHE HAD SEVERE BONE LOSS, AND METAL SHAVINGS BASICALLY FALLEN OFF INTO HER BODY. THE SECOND REVISION WHICH WAS AN EMERGENCY HIP REPLACEMENT WAS PERFORMED (ON (B)(6) 2025) WITH NON-STRYKER IMPLANTS. IT WAS DISCOVERED SHE HAD SEVERE BONE LOSS. PER THE ORTHOPEDIC SURGEON; IT LOOKED LIKE A BOMB HAD GONE OFF ON HER LEG AND THE SURGERY WAS INTENSE. THIS HAS LEFT HER RELYING ON SOME SORT OF WALKING ASSISTANCE DEVICE. PT. FURTHER STATED HER QUALITY OF LIFE HAS COMPLETELY CHANGED; SHE'S BEE
Patient problems: Insufficient Information; Osteolysis; Pain
MAUDE report 25659003 ↗InjurySep 22, 2025Degraded; Detachment of Device or Device Component; Degraded; Detachment of Device or Device Component
THE FOLLOWING INFORMATION WAS PROVIDED: CITATION STEM WITH V40 METAL HEAD. WORN TRUNNION CAUSED DISSOCIATION. REVISED WITH 2B STEM AND STRYKER MDM. RIGHT SIDE.
Patient problems: Ambulation or Postural Difficulties; Insufficient Information
MAUDE report 23110359 ↗InjuryJun 9, 2025Degraded; Material Erosion; Degraded; Material Erosion
NO NEW INFORMATION.
Patient problems: Ambulation or Postural Difficulties; Fall
MAUDE report 22165320 ↗InjuryFeb 10, 2025Material Erosion; Detachment of Device or Device Component; Material Erosion; Detachment of Device or Device Component
IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED. AS REPORTED BY REP: "PATIENT STARTED COMPLAINING A FEW MONTHS AGO ABOUT HER HIP FEELING ABNORMAL. X-RAYS REVEALED A PROBLEM WITH THE FEMORAL HEAD AND NECK COMBINATION. THE TRUNNION WAS WORN OFF. THE LINER WAS BASICALLY WORN AWAY." THE HEAD PARTIALLY CAME OFF THE TRUNNION BECAUSE OF THE WEAR.
Patient problems: Discomfort
MAUDE report 21342913 ↗InjuryJan 4, 2024Degraded; Degraded
EXTENSIVE PELVIC OSTEOLYSIS IN PSEUDOTUMOR IN MOM METAL-ON-METAL THA (CITATION 5 STEM).
Patient problems: Osteolysis
MAUDE report 18444611 ↗InjuryOct 26, 2023Material Erosion; Material Erosion
IT IS REPORTED BY COUNSEL THAT CLAIMANT UNDERWENT A RTHA ON (B)(6) 2013 WHERE A CITATION TMZF HIP STEM AND A LFIT V40 FEMORAL HEAD WERE IMPLANTED. ALLEGEDLY SHE WAS REVISED ON (B)(6) 2020 DUE TO PAIN, ELEVATED COBALT AND CHROME LEVELS, AND PSEUDOTUMOR.
Patient problems: Metal Related Pathology
MAUDE report 18009641 ↗InjuryJun 5, 2023Degraded; Degraded
REP RECEIVED A TEXT MESSAGE FROM A SURGEON WITH A PICTURE OF AN EXPLANTED CITATION STEM. SURGEON IS ASKING IF THE DEVICE WAS PART OF A RECALL. PER RESPONSE: "¿THE REASON FOR REVISION IS A TITANIUM ADVERSE LOCAL TISSUE REACTION. IT WAS A CERAMIC HEAD ON A POLYETHYLENE LINER, SHE HAD MULTIPLE HEAD/LINER AND CUP REVISIONS SINCE THE ORIGINAL SURGERY, THE STEM WAS THE ONLY ORIGINAL COMPONENT.¿ "NO OTHER IMPLANT INFORMATION WAS PROVIDED PATIENT HAD PREVIOUS SURGERIES PERFORMED AT DIFFERENT HOSPITAL."
Patient problems: Foreign Body Reaction; Metal Related Pathology
MAUDE report 17064126 ↗InjuryMar 22, 2023Degraded; Material Erosion; Fracture; Detachment of Device or Device Component; Degraded; Material Erosion; Fracture; Detachment of Device or Device Component
WIFE REPORTED HER HUSBAND HAD A REVISION OF THE LEFT HIP ON (B)(6) 2022 DUE TO THE "TWO METALS BEING WORN DOWN TO FINE PENCIL TIPS". PRIMARY SURGERY WAS DONE ON (B)(6) 2007. UPDATE: PER PATIENT MEDICAL RECORDS, IT WAS INDICATED THAT THE PATIENT WAS REVISED DUE TO DISASSOCIATION OF THE HEAD FROM THE STEM, FRACTURE OF THE FEMORAL STEM TRUNNION, METALLOSIS AND OSTEOLYSIS, DESTRUCTION OF ABDUCTORS, HETEROTOPIC OSSIFICATION AND FRACTURE OF THE GREATER TROCHANTER WHEREBY THE STEM, HEAD AND LINER WERE EXPLANTED AND THE PATIENT WAS CONVERTED TO A RESTORATION MODULAR CONSTRUCT WITH DALL MILES GRIP PLATE AND CABLING FOR FIXATION. IT WAS ALSO REPORTED THAT THE SHELL WAS SLIGHTLY MORE VERTICAL THAN IDEAL BUT REMOVAL WOULD HAVE CAUSED SIGNIFICANT BONE LOSS, SO IT WAS LEFT IMPLANTED. DURING REVISION SURGERY, THE FOLLOWING WERE PERFORMED: "DEBRIDEMENT OF CHRONIC METALLIC WEAR DEBRIS AND OSTEOLYSIS," "OPEN REDUCTION INTERNAL FIXATION LEFT GREATER TROCHANTER FRACTURE," AND "RESECTION OF HETEROTOPIC OSSIFICATION." DESPITE THE REPORTED PROXIMAL BONE EROSIONS, THE FEMORAL STEM WAS REPORTED TO BE WELL-FIXED AND REMOVAL WAS INTENSIVE.
Patient problems: Ambulation or Postural Difficulties; Bone Fracture(s); Extraskeletal ossification; Insufficient Information; Joint Laxity; Muscle/Tendon Damage; Osteolysis; Pain
MAUDE report 16590146 ↗InjuryFeb 28, 2023Fracture; Fracture
IT WAS REPORTED THE PATIENT'S RIGHT HIP WAS REVISED DUE TO THE NECK OF THE STEM (DISTAL TO THE HEAD) BREAKING. THE STEM, HEAD, AND ADM/ MDM POLY INSERT WERE REVISED TO AN ADM/ MDM POLY INSERT AND COMPETITOR FEMORAL IMPLANTS. REP CONFIRMED THAT THERE ARE NO ALLEGATIONS (INCLUDING DAMAGE) AGAINST THE REVISED HEAD OR POLY. REP ALSO CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.
Patient problems: Ambulation or Postural Difficulties; Insufficient Information
MAUDE report 16450558 ↗InjuryFeb 24, 2023Detachment of Device or Device Component; Noise, Audible; Detachment of Device or Device Component; Noise, Audible
IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WITH AN LFIT COCR V40 FEMORAL HEAD ON HIS RIGHT HIP ON OR ABOUT (B)(6) 2007. ALLEGEDLY IN (B)(6) 2022 PATIENT DEVELOPED AN AUDIBLE "CLICKING" SOUND IN HIS RIGHT HIP UPON MOVEMENT OF THAT HIP AND SUBSEQUENT DIAGNOSTIC IMAGING STUDIES AND ASPIRATION OF HIS RIGHT HIP REVEALED EARLY SIGNS OF A SIMILAR BREAKDOWN (DISSOCIATION) WHICH WAS PREVIOUSLY OBSERVED ON HIS LEFT HIP. IT IS FURTHER ALLEGED THAT IN (B)(6) 2022 HE WAS REQUIRED TO UNDERGO A REVISION SURGERY.
Patient problems: Ambulation or Postural Difficulties
MAUDE report 16433969 ↗InjuryFeb 2, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED BY THE PATIENT 'S ATTORNEY THAT ALLEGEDLY THE PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2012 AND WAS IMPLANTED WITH A 36 MM +5 LFIT ANATOMIC V40 FEMORAL HEAD AND AN CITATION TMZF HIP STEM. THE PATIENT WAS REVISED ON (B)(6) 2021 DUE TO HEAD DISASSOCIATION.
Patient problems: Ambulation or Postural Difficulties
MAUDE report 16282763 ↗InjuryAug 3, 2022Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED. PATIENT FELL AND HEAD DISSOCIATION WAS DIAGNOSED (UNKNOWN WHICH ONE CAUSED THE OTHER). INTRA-OPERATIVELY, TRUNNION WEAR WAS NOTED. THE STEM, HEAD, AND LINER WERE REVISED. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED LINER. REP CONFIRMED HE WILL PROVIDE ALL PICTURES AND DOCUMENTS AVAILABLE TO HIM FROM THE HOSPITAL AND SURGEON.
Patient problems: Fall
MAUDE report 15154612 ↗InjuryApr 14, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO HEAD DISSOCIATION AND TRUNNION WEAR. THE STEM, HEAD AND LINER WERE REVISED. NO ALLEGATIONS AGAINST THE LINER WERE REPORTED TO THE REP. PATIENT WAS REVISED TO A RESTORATION MODULAR STEM CONSTRUCT, CERAMIC HEAD, AND ADM/ MDM LINER CONSTRUCT. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.
Patient problems: Ambulation or Postural Difficulties
MAUDE report 14114918 ↗InjuryNov 19, 2021Fracture; Fracture
IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO THE TRUNNION OF THE CITATION STEM BREAKING OFF. SURGEON REPORTED PATIENT IS VERY ACTIVE, CYCLING 30 MILES PER DAY. THE STEM AND HEAD WERE REVISED. THERE ARE NO ALLEGATIONS AGAINST THE REVISED HEAD.
Patient problems: Ambulation or Postural Difficulties; No Clinical Signs, Symptoms or Conditions
MAUDE report 12844036 ↗
Other Howmedica Osteonics Corp. products
- Triathlon608 models · 3,524 reports · 15 recalls
- Scorpio107 models · 113 reports · 28 recalls
- Trident160 models · 1,280 reports · 2 recalls
- Accolade57 models · 1,228 reports
- Duracon58 models · 65 reports · 16 recalls
- LFIT23 models · 852 reports
- TRIDENT II42 models · 188 reports · 12 recalls
- INSTRUMENT131 models · 290 reports · 7 recalls
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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