MRSRecalls & reported problems across all models
Howmedica Osteonics Corp. · 25 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 53
- Deaths reported
- 0
- Injuries reported
- 49
- Recalls
- 0
We found 25 models of MRS by Howmedica Osteonics Corp. in the FDA's device registry (GUDID). Together they are named in 53 adverse event reports in the FDA's MAUDE database, received between Jun 30, 2017 and Jun 29, 2026 — classified as 49 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Fracture” (16 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 MRS problems
Device problems
- Fracture16
- Loss of Osseointegration14
- Adverse Event Without Identified Device or Use Problem6
- Break5
- Osseointegration Problem5
- Corroded2
- Failure to Osseointegrate2
- Insufficient Device Problem Information2
Patient problems
- Inadequate Osseointegration18
- Injury16
- Ambulation or Postural Difficulties7
- Insufficient Information7
- Pain7
- Bone Fracture(s)3
- No Consequences Or Impact To Patient3
- Fall2
MRS models
25 models, most reported first. Each model has its own page with its reports, recalls and device details.
- MRS 6485-3-011PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER9 reports
- MRS 6485-3-111PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER5 reports
- MRS 6485-3-113PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER5 reports
- MRS 6485-3-000PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER4 reports
- MRS 6485-3-013PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER4 reports
- MRS 6485-3-811PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER4 reports
- MRS 6485-3-117PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER2 reports
- MRS 6485-3-313PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER2 reports
- MRS 6487-1-040PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED2 reports
- MRS 6485-2-608PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- MRS 6485-3-008PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- MRS 6485-3-010PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- MRS 6485-3-211PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- MRS 6485-3-310PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- MRS 6485-3-311PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- MRS 6485-3-318PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- MRS 6485-3-617PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- MRS 6485-3-815PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- MRS 6485-3-813PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- MRS 6487-5-044PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED1 report
- MRS 6487-3-115PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED1 report
- MRS 6487-3-075PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED1 report
- MRS 6485-3-015PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- MRS 6485-3-115PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- MRS 6487-5-075PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED1 report
Recent MRS adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJun 29, 2026Loss of Osseointegration
REVISION OF STRYKER GMRS10X102MM STEM, 40MM EXT PIECE AND DUE TO ASEPTIC LOOSENING. SLEEVE AND POLY CHANGED ALSO. REVISED TO ADLER SEGMENTAL STEM WITH COLLAR AND CUSTOM 35MM ADAPTOR (FROM ADLER STEM TO STRYKER DISTAL FEM GMRS COMPONENT).
Patient problems: Inadequate Osseointegration
MAUDE report 25658441 ↗InjuryDec 11, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE PATIENT UNDERWENT LEFT HIP REVISION SURGERY. HALF A MONTH AGO, THE PATIENT SUDDENLY EXPERIENCED LEFT HIP PAIN WITH LIMITED MOBILITY WHILE USING THE TOILET AT HOME. ON (B)(6) 2025, DURING A FOLLOW-UP EXAMINATION AT THE LOCAL HOSPITAL, AN X-RAY WAS PERFORMED, DIAGNOSING "LEFT PROSTHETIC JOINT DISLOCATION." THE PATIENT WAS THEN ADMITTED TO OUR HOSPITAL FOR CLOSED REDUCTION UNDER ANESTHESIA, WITH GOOD POSTOPERATIVE RECOVERY.
Patient problems: Joint Dislocation
MAUDE report 23776174 ↗InjuryOct 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE FOLLOWING INFORMATION WAS PROVIDED: AS PER PSS IMPLANT REQUEST: LOOSENING GMRS PROXIMAL HUMERUS PROSTHESIS WITH PATHOLOGICAL FRACTURE. HISTORY OF PERIOSTEAL CHONDROSARCOMA PROXIMAL HUMERUS, EXCISION AND REPLACEMENT WITH GMRS PROXIMAL HUMERUS DONE IN 2015, DEFAULTED FOLLOW UP, CAME BACK WITH LOOSENING WITH PERIPROSTHETIC FRACTURE, BIOPSY REVEALED NO EVIDENCE OF TUMOUR RECURRENCE. PLAN FOR REVISION.
Patient problems: Periprosthetic fracture
MAUDE report 23360550 ↗InjuryOct 20, 2025Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem; Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem
NO NEW INFORMATION.
Patient problems: Bone Fracture(s); Inadequate Osseointegration; Periprosthetic fracture
MAUDE report 23334763 ↗InjurySep 15, 2025Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem
THE FOLLOWING IS REPORTED IN PSS CASE: REVISION DUE TO LOOSENING OF THE STEM. REVISION TO STRYKER MRS DISTAL HUMERUS SYSTEM. IMPLANT: MRS CEMENTLESS STEM WITH EXTRA-CORTICAL PLATE. LEFT SIDE. PLANNED SURGERY DATE (B)(6) 2025. UPDATE: OSTEOSARCOMA IS NOT THE CAUSE FOR LOOSENING OF STEM. PATIENT HAS BEEN IN PAIN MORE THAN 6 MONTHS. WE FOUND THAT LOOSENING OF THE STEM IS THE MOST LIKELY REASON, NO TUMOR RECURRENCE FOUND. NO INFECTION NOTED.
Patient problems: Inadequate Osseointegration
MAUDE report 23059578 ↗InjuryAug 26, 2025Osseointegration Problem; Osseointegration Problem
REVISION OF DISTAL FEMORAL GMRS, TO TOTAL FEMUR GMRS. GMRS REVISED DUE TO LOOSENING. NOTIFICATION OF REVISION ONLY.
Patient problems: Inadequate Osseointegration
MAUDE report 22892453 ↗InjuryJul 23, 2024Corroded; Corroded
IT WAS REPORTED THE PATIENT'S LEFT KNEE WAS REVISED DUE TO COMPLAINT OF PAIN. ORIGINAL PLAN WAS TO RESURFACE THE PATIENT'S NATIVE PATELLA. THOUGH PATIENT WAS NEGATIVE FOR INFECTION, SURGEON DECIDED TO REVISE THE DISTAL FEMORAL COMPONENT, STEM AND EXTENDER OUT OF AN ABUNDANCE OF CAUTION. WHEN THE DEVICES WERE DISSOCIATED, CORROSION WAS NOTED AT THE JUNCTION OF THE DISTAL FEMUR AND EXTENSION AND THE JUNCTION OF THE EXTENSION AND STEM. REP CAN PROVIDE PICTURES AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.
Patient problems: Pain
MAUDE report 19806104 ↗InjuryJul 31, 2023Loss of Osseointegration; Loss of Osseointegration
LEFT DISTAL FEMUR 1ST STAGE REVISION SURGERY ABOVE KNEE CAST DUE TO ASEPTIC LOOSENING OF THE FEMUR STEM. WIDE FEMUR MEDULLARY CANAL MORE THAT 17MM- NEED CUSTOM MADE STEM.
Patient problems: Inadequate Osseointegration
MAUDE report 17422685 ↗InjuryJul 17, 2023Failure to Osseointegrate; Loss of Osseointegration; Failure to Osseointegrate; Loss of Osseointegration
A PATIENT-SPECIFIC IMPLANT PRESCRIPTION WAS RECEIVED FOR THE PATIENT'S LEFT GMRS DISTAL FEMUR. NOTED ON THE FORM: "LOOSENING STEM." AS AN FIRST STAGE OF REVISION, CEMENT SPACER FIXED. UPDATE: PATIENT WAS UNDERWENT STAGE 1 OF A LEFT DISTAL FEMUR REVISION ON (B)(6) 2023 DUE TO ASEPTIC LOOSENING OF THE FEMUR STEM. THE FEMORAL COMPONENTS WERE EXPLANTED AND THE PATIENT WAS CLOSED BACK UP WITH A CEMENT SPACER AND ABOVE THE KNEE CAST APPLIED AS THE SURGEON REQUIRES A CUSTOM DEVICE TO ACCOMMODATE THE PATIENT'S WIDE FEMUR MEDULLARY CANAL OF MORE THAT 17MM. THE SECOND STAGE OF THIS REVISION WAS REPORTED TO BE PLANNED FOR (B)(6) 2023 DURING WHICH THE CUSTOM FEMORAL IMPLANT WOULD BE IMPLANTED.
Patient problems: Inadequate Osseointegration
MAUDE report 17339701 ↗InjuryJun 28, 2023Loss of Osseointegration; Loss of Osseointegration
THIS PI IS FOR THE FIRST REVISION OF THE PATIENT'S LEFT DISTAL FEMUR ON (B)(6) 2023. IN PROVIDING INFORMATION FOR A CASE (IMPENDING REVISION OF PATIENT'S LEFT DISTAL FEMUR/ KNEE), TERRITORY MANAGER PROVIDED INFORMATION THAT THE PATIENT HAD A PRIOR REVISION ON (B)(6) 2023 DUE TO LOOSENING OF THE FEMORAL STEM.
Patient problems: Inadequate Osseointegration
MAUDE report 17222033 ↗InjuryJun 14, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
POSTOPERATIVELY, THE GMRS DISTAL FEMORAL COMPONENT WAS DISLODGED FROM THE STEM. UPDATE: " AS FOR THE POSTOPERATIVE COURSE, CLEANSING DEBRIDEMENT WAS PERFORMED UNDER LOCAL ANESTHESIA FOR SUPERFICIAL INFECTION OF THE POSTOPERATIVE WOUND. AFTER THAT, THE PATIENT FELL AND THE WOUND WAS OPENED AGAIN AND THE WOUND WAS RE-SUTURED. WHEELCHAIR SELF-PROPELLED AND DISCHARGED. AT THE END OF (B)(6) 2023, THE PATIENT HAD RIGHT KNEE PAIN WHEN TAKING A SHOWER AND WHEN SHE UNDERWENT AN EXAMINATION IN MAY, IT WAS CONFIRMED THAT THE IMPLANT HAD FALLEN OUT. IN ADDITION, RECURRENCE OF OSTEOSARCOMA WAS RECOGNIZED FROM THE TISSUE DURING REVISION SURGERY."
Patient problems: Insufficient Information; Pain
MAUDE report 17123933 ↗InjuryApr 18, 2023Loss of Osseointegration; Loss of Osseointegration
IT HAS BEEN REPORTED "REPORTED BY DISTRIBUTOR THAT PATIENT PAIN, IMPLANT LOOSENING, AFTER X RAY, SURGEON SUGGEST TO PERFORM THE REVISION AND THE REVISION DATE IS NOT IDENTIFIED. YET."
Patient problems: Inadequate Osseointegration; Pain
MAUDE report 16760239 ↗InjuryMar 28, 2023Degraded; Fracture; Degraded; Fracture
BROKEN 203X13MM CURVED GMRS STEM IN SITU IN PATIENT REVISION SURGERY REQUIRED SURGEON REPORTED THAT WHILE THE PATIENT WAS WALKING, THEY FELT THEIR LEG BUCKLE. FRACTURED COMPONENT CONFIRMED BY X-RAY.
Patient problems: Fall; Insufficient Information
MAUDE report 16625696 ↗InjuryFeb 1, 2023Loss of Osseointegration; Loss of Osseointegration
A PATIENT SPECIFIC IMPLANT REQUEST WAS RECEIVED FOR THE PATIENT'S RIGHT DISTAL FEMUR. NOTED ON THE FORM: "...S/P RESECTION AND RECONSTRUCTION RIGHT DISTAL FEMUR WITH STRYKER (B)(4) AND NOW SECOND EPISODE OF ASEPTIC LOOSENING... RETAINING 8MM LARGE ALL0POLY TIBIA." PROPOSED DATE OF SURGERY IS (B)(6) 2023.
Patient problems: Inadequate Osseointegration
MAUDE report 16276120 ↗InjuryDec 15, 2022Loss of Osseointegration; Loss of Osseointegration
A PATIENT SPECIFIC IMPLANT REQUEST FORM WAS RECEIVED FOR THE PATIENT'S DISTAL FEMUR/ PROXIMAL TIBIA REPLACEMENTS. "FAILURE OF DISTAL TIBIAL CEMENTED STEM DUE TO LOOSENING." ALL COMPONENTS TO BE REVISED.
Patient problems: Inadequate Osseointegration
MAUDE report 15986005 ↗
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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