AluminaRecalls & reported problems across all models
Howmedica Osteonics Corp. · 16 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
- 40
- Recalls
- 0
We found 16 models of Alumina 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 Apr 12, 2017 and Apr 3, 2026 — classified as 40 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Fracture” (17 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 Alumina problems
Device problems
- Fracture17
- Noise, Audible14
- Break6
- Insufficient Device Problem Information5
- Device Dislodged or Dislocated3
- Crack2
- Degraded2
- Unstable2
Patient problems
- Injury22
- Pain17
- Ambulation or Postural Difficulties6
- Insufficient Information4
- Fall3
- Metal Related Pathology3
- No Known Impact Or Consequence To Patient3
- Discomfort2
Alumina models
16 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Alumina 6565-0-232Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented6 reports
- Alumina 6565-0-128Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented5 reports
- Alumina 6565-0-036Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented5 reports
- Alumina 6565-0-032Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented4 reports
- Alumina 17-3200EProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented4 reports
- Alumina 17-32-3EProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented2 reports
- Alumina 6565-0-132Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented2 reports
- Alumina 6565-0-136Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented2 reports
- Alumina 6565-0-236Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented2 reports
- Alumina 6565-0-028Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented2 reports
- Alumina 17-3205EProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented2 reports
- Alumina 17-3605EProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented2 reports
- Alumina 17-3600EProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented2 reports
- Alumina 6565-0-228Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- Alumina 17-2800EProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- Alumina 17-2805EProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
Recent Alumina adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryApr 3, 2026Noise, Audible
THE FOLLOWING INFORMATION WAS PROVIDED: HIP REVISION OF CERAMIC ON CERAMIC HIP DUE TO PATIENT COMPLAINT OF "SQUEAKING." LEFT HIP.
Patient problems: Insufficient Information
MAUDE report 24779753 ↗InjuryFeb 17, 2026Fracture
THE FOLLOWING INFORMATION WAS PROVIDED: THE MPS REPORTED THAT: "I AM REPORTING A MEDICAL DEVICE VIGILANCE CASE FOLLOWING A MAKO PTH ON THE LEFT SIDE PERFORMED ON (B)(6) 2023. AFTER FALLING OUT OF BED, THE PATIENT RETURNED A FEW DAYS AGO AND THE SCAN SHOWED THAT THE ALUMINA CERAMIC HEAD HAD EXPLODED." "THE REVISION IS SCHEDULED FOR TODAY. WE WILL KEEP THE HEAD AND THE PIECES TO SEND THEM BACK TO THE MANUFACTURER AND GET FEEDBACK ON THE MATERIAL ANALYSIS."
Patient problems: Fall
MAUDE report 24362417 ↗InjurySep 16, 2025Fracture; Fracture
InjuryApr 9, 2024Fracture; Noise, Audible; Fracture; Noise, Audible
IT WAS REPORTED THAT "PATIENT ALLEGEDLY FELT SOME SQUEAKING AND MILD GRINDING OF HER HIP IMPLANT. SHE CLAIMS THAT HER HIP GAVE OUT WHILE STEPPING OUT OF THE SHOWER. PATIENT WAS BEING REVISED FOR POSSIBLE FRACTURED CERAMIC HEAD."
Patient problems: Ambulation or Postural Difficulties; Insufficient Information
MAUDE report 19070224 ↗MalfunctionFeb 26, 2024Fracture; Fracture
ON JANUARY 29, 2024, AN ADVERSE EVENT OCCURRED DURING THE IMPLANTATION OF THE CERAMIC ALUMINA HEAD REF: 6565-0-036, SN:(B)(6). WHILE ADJUSTING THE HIP JOINT AND CHECKING THE PROPER ROTATION OF THE JOINT ( ABDUCTION, ADDUCTION OF THE HIP JOINT), THE ALUMINA HEAD THAT HAD ALREADY BEEN IMPLANTED ON THE ACCOLADE II STEM BROKE. SINCE THE SAME HEAD ( ALUMINA IN SIZE 36) WAS AVAILABLE AT THE STRYKER IMPLANT COMMISSARY IN THE OPERATING THEATER, THE PROCEDURE WAS COMPLETED WITHOUT A PROBLEM AND AT THE RIGHT TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18785513 ↗InjuryJan 14, 2024Fracture; Fracture
CUSTOMER REPORTED : "HIP REVISION RIGHT SIDE FOR SHATTERED ALUMINA CERAMIC HEAD."
Patient problems: Insufficient Information
MAUDE report 18509784 ↗InjuryNov 14, 2023Fracture; Fracture
"THE PATIENT HAD PAIN AND MOBILITY DIFFICULTIES." "THE IMPLANT BROKE INSIDE THE PATIENT. A SURGICAL RE-APPROACH WAS PERFORMED, CHANGING THE HEAD AND INSERT."
Patient problems: Ambulation or Postural Difficulties; Pain
MAUDE report 18136314 ↗InjuryJan 23, 2023Fracture; Fracture
THE FOLLOWING WAS REPORTED: THE PATIENT PRESENTED WITH COMPLAINTS OF PAIN AND A SHORTER LIMB. DURING REVISION SURGERY ON THE (B)(6) 2022 IT WAS FOUND THAT THE CERAMIC HEAD HAD CRACKED AND CHIPPED. THE PATIENT'S CERAMIC HEAD WAS REPLACED WITH A METAL ONE AND THE MDM INSERT WAS REPLACED WITH A NEW ONE.
Patient problems: Pain; Unequal Limb Length
MAUDE report 16223446 ↗InjuryApr 20, 2022Noise, Audible; Noise, Audible
AS REPORTED: "LEFT REVISION HIP REPLACEMENT SURGERY. SURGEON COMMENT: PATIENT COMPLAINED OF 'SQUEAKING.'" AN ALUMINA HEAD AND LINER WERE REVISED TO A BIOLOX HEAD AND SLEEVE AND A POLY INSERT.
Patient problems: Ambulation or Postural Difficulties
MAUDE report 14160177 ↗InjuryApr 5, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO PAIN IN FLEXION AND AUDIBLE CLICKING. A CERAMIC HEAD, INSERT AND METAL SLEEVE WERE REVISED TO A CERAMIC HEAD WITH POLY INSERT. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.
Patient problems: Pain
MAUDE report 14009758 ↗InjuryOct 25, 2021Unstable; Unstable
IT WAS REPORTED THAT THE PATIENT'S HIP WAS REVISED DUE TO INSTABILITY. THE HEAD AND LINER WERE REVISED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.
Patient problems: Ambulation or Postural Difficulties
MAUDE report 12693852 ↗InjuryJul 1, 2021Material Erosion; Adverse Event Without Identified Device or Use Problem; Material Erosion; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT REQUIRED REVISION HIP SURGERY FOLLOWING IDENTIFICATION OF ELEVATED TI LEVELS AND A WORN (TITANIUM SLEEVE PORTION) OF A CERAMIC LINER HAD TO BE REMOVED IN ADDITION TO AN ALUMINA HEAD. IT WAS FURTHER REPORTED THAT THE PATIENT WAS REVISED USING A NEW POLY LINER COUPLED WITH A C TAPER SLEEVE AND DELTA 36MM HEAD.
Patient problems: Metal Related Pathology
MAUDE report 12104518 ↗InjuryJun 10, 2021Unstable; Unstable
A 2012 OPERATIVE REPORT FOR THE PATIENT'S LEFT HIP WAS PROVIDED. NOTED IN THE REPORT: "INSTABILITY OF THE LEFT HIP JOINT SECONDARY TO CEMENTLESS TOTAL HIP REPLACEMENT ON THE LEFT...FEMORAL HEAD EXCHANGE, REVISION TO A METAL HEAD, DIAMETER 28MM, LENGTH +12MM, TAPER V40...JOINT IS OPENED FROM THE DORSAL, REVEALING MINOR EFFUSION. A SMEAR IS SENT IN FOR BACTERIOLOGY...NO LONGER POSSIBLE TO ATTACH A CERAMIC HEAD, BECAUSE THE PROSTHESIS TAPER EXHIBITED SCRATCHES AND AN EXTENSION BY 12MM WITH CERAMIC HEAD, DIAMETER 28MM, IS NOT POSSIBLE." THE REPORT NOTES A 45 MINUTE INTRA-OPERATIVE DELAY TO HAVE THE NEW FEMORAL HEAD DELIVERED BY TAXI AS ONE WAS NOT AVAILABLE IN THE O.R. AN OPERATIVE REPORT FOR A REVISION ON (B)(6) 2016 NOTES: "STATUS SECONDARY TO REVISION OF THE MODULAR HEAD SYSTEM PERFORMED ON (B)(6) 2012 IN THE PRESENCE OF RECURRENT DISLOCATION." ONLY THE FEMORAL HEAD WAS REVISED IN 2012.
Patient problems: Joint Laxity
MAUDE report 11972735 ↗InjuryMar 26, 2021Fracture; Fracture
BROKEN CERAMIC CUP. UPDATED EVENT AS PER SALES REP: THIS WAS REVISION DUE THE FACT THAT THE CERAMIC HEAD WAS BROKEN.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 11575388 ↗InjuryNov 25, 2020Detachment of Device or Device Component; Insufficient Device Problem Information; Noise, Audible; Detachment of Device or Device Component; Insufficient Device Problem Information; Noise, Audible
PATIENT GOT A RIGHT HIP REVISION DUE TO ¿SQUEAKING¿ COMPLAINTS. PATIENT COMPLAINT OF GRINDING, POPPING FEELING AND AUDIBLE SQUEAK AND GRINDING. PATIENT ALSO EXPERIENCING PAIN. CUP AND LINER WERE WELL FIXATED. HEAD EASILY REMOVED FROM TRUNNION. NO MARKED STRIPING ON CERAMIC LINER OR OUTER HEAD - BUT BROWN DISCOLOURATION INSIDE HEAD. HEAD LOOSE ON TRUNNION. RUST MARKS ON CUP RIM. FEMORAL STEM UNREMARKABLE, FIXATED AND RETAINED.
Patient problems: Pain
MAUDE report 10903163 ↗
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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