MRHRecalls & reported problems across all models
Howmedica Osteonics Corp. · 35 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 259
- Deaths reported
- 0
- Injuries reported
- 254
- Recalls
- 0
We found 35 models of MRH by Howmedica Osteonics Corp. in the FDA's device registry (GUDID). Together they are named in 259 adverse event reports in the FDA's MAUDE database, received between Mar 21, 2017 and Aug 27, 2026 — classified as 254 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Fracture” (51 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 MRH problems
Device problems
- Adverse Event Without Identified Device or Use Problem100
- Fracture51
- Insufficient Device Problem Information47
- Loss of Osseointegration31
- Unstable18
- Degraded11
- Break8
- Detachment of Device or Device Component8
Patient problems
- Unspecified Infection88
- Injury72
- Ambulation or Postural Difficulties40
- Insufficient Information38
- Inadequate Osseointegration29
- Pain26
- Joint Laxity17
- Bone Fracture(s)14
MRH models
35 models, most reported first. Each model has its own page with its reports, recalls and device details.
- MRH 6481-3-210PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER25 reports
- MRH 6481-1-110PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER19 reports
- MRH 6481-3-213PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER18 reports
- MRH 6481-3-310PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER14 reports
- MRH 6481-2-120PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER14 reports
- MRH 6481-3-110PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER14 reports
- MRH 6481-1-111PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER13 reports
- MRH 6481-1-120PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER12 reports
- MRH 6481-2-130PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER12 reports
- MRH 6481-1-121PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER11 reports
- MRH 6481-2-100PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER10 reports
- MRH 6481-3-313PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER9 reports
- MRH 6481-1-100PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER8 reports
- MRH 6481-2-110PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER8 reports
- MRH 6481-3-316PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER7 reports
- MRH 6481-3-111PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER7 reports
- MRH 6481-3-112PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER7 reports
- MRH 6481-3-216PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER6 reports
- MRH 6481-1-101PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER6 reports
- MRH 6481-1-131PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER6 reports
- MRH 6481-3-220PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER5 reports
- MRH 6481-2-103PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER5 reports
- MRH 6481-2-140PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER5 reports
- MRH 6481-3-320PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER3 reports
- MRH 6481-1-130PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER3 reports
- MRH 6481-3-113PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER3 reports
- MRH 6481-3-224PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- MRH 6481-3-324PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- MRH 6481-1-141PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- MRH 6481-2-104PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- MRH 6481-2-133PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- MRH 6481-2-150PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- MRH 6481-1-200PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- MRH 6481-1-230PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- MRH 6481-3-100PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER1 report
Recent MRH adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryAug 27, 2026Adverse Event Without Identified Device or Use Problem
Revision/exploration of distal femur GMRS R due to pain. Revised distal femur and articulating components- patella added. No issue with devices reported. Notification only.
Patient problems: Pain
MAUDE report 50476269 ↗InjuryAug 25, 2026Adverse Event Without Identified Device or Use Problem
As reported: "Patient revised due to chronic infection. No other information available due to hospital policy." Surgery performed 1 day after date of awareness. All components except a baseplate and stem(s) were removed. Left DFR.Revision, infection.
Patient problems: Unspecified Infection
MAUDE report 50430781 ↗InjuryAug 25, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50422111 ↗InjuryAug 24, 2026Fracture
Patient problems: Insufficient Information
MAUDE report 50416220 ↗InjuryJun 15, 2026Adverse Event Without Identified Device or Use Problem
THE FOLLOWING INFORMATION WAS PROVIDED: REVISION OF PATIENT S.W. DISTAL FEMUR GMRS ORIGINALLY PUT IN ON (B)(6) 2025 (ORIGINAL CASE OA 11897482) DUE TO INFECTION AT (B)(6) HOSPITAL ON (B)(6) 2026 TO T2 NAIL CEMENT SPACER (STAGE 1).
Patient problems: Unspecified Infection
MAUDE report 25511432 ↗InjuryMay 28, 2026Unstable
THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED THAT UPON REVISION, POLYETHYLENE WEAR WAS OBSERVED ON THE TIBIAL SLEEVE, TIBIAL INSERT, BUMPER. ROTATING COMPONENT, DISTAL FEMUR. PATIENT REVISED DUE TO RIGHT KNEE INSTABILITY. PATIENT REVISED WITH NEW, ANALAGOUS COMPONENTS.
Patient problems: Joint Laxity
MAUDE report 25314903 ↗InjuryMay 27, 2026Fracture
THE FOLLOWING INFORMATION WAS PROVIDED: A FRACTURE OF THE FEMORAL COMPONENT OF THE GMRS K-TEP WAS DETECTED DURING A PREOPERATIVE X-RAY. REVISION ON (B)(6) 2026.
Patient problems: Insufficient Information; Joint Laxity
MAUDE report 25302973 ↗InjuryMay 19, 2026Adverse Event Without Identified Device or Use Problem
THE FOLLOWING INFORMATION WAS PROVIDED: REVISION OF FEMUR DISTAL FEMUR GMRS AND TOTAL HIP REPLACEMENT (NOT STRYKER PRODUCTS) INSITU. NO REPORTED ISSUE WITH STRYKER DEVICES.
Patient problems: Insufficient Information
MAUDE report 25213629 ↗InjuryMay 12, 2026Adverse Event Without Identified Device or Use Problem
THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED THAT AFTER IMPLANTATION OF A DISTAL FEMORAL CONSTRUCT INCLUDING CUSTOM IMPLANTS, PATIENT HAS DEVELOPED AN INFECTION. SURGEON'S PLAN IS TO REMOVE ALL IMPLANTS EXCEPT THE RESTORATION MODULAR STEM (USED IN THE DISTAL FEMUR). FOR THE CUSTOM GMRS RESTORATION MODULAR ADAPTER AND CUSTOM LOCKING BOLT, SURGEON'S PLAN IS TO REMOVE THE DEVICES, WASH THEM IN BETADINE, AND RE-IMPLANT THEM. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.
Patient problems: Unspecified Infection
MAUDE report 25147072 ↗InjuryApr 28, 2026Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event
THE FOLLOWING INFORMATION WAS PROVIDED: REVISION MRH DUE TO INFECTION. WASHOUT PROCEDURE AND MINOR REVISION. NO STRYKER REPRESENTATIVE PRESENT. INFORMED BY NURSING STAFF AFTER THE EVENT.
Patient problems: Unspecified Infection
MAUDE report 25019014 ↗InjuryApr 14, 2026Degraded; Adverse Event Without Identified Device or Use Problem
THE FOLLOWING INFORMATION WAS PROVIDED: REVISION KNEE SURGERY - INFECTION.
Patient problems: Unspecified Infection
MAUDE report 24870050 ↗InjuryMar 18, 2026Fracture
THE FOLLOWING INFORMATION WAS PROVIDED: THIS PI IS FOR THE ALLEGATION OF IMPLANT BREAKAGE AFTER REVISION. I WAS DIAGNOSED WITH BONE CANCER IN MY RIGHT TIBIA IN 2015. IN (B)(6) OF THAT YEAR, FOLLOWING FOUR MONTHS OF CHEMOTHERAPY, THAT CANCER-AFFECTED AREA WAS SURGICALLY REMOVED AND SEVERAL STRYKER DEVICES WERE IMPLANTED. THE DEVICES CONTAINED BOTH TIBIAL AND FEMORAL COMPONENTS. ATTACHED PLEASE FIND THE SERIAL NUMBERS OF ALL THE STRYKER DEVICES INCLUDED IN THAT SURGERY. IN (B)(6) OF 2022, THE FEMORAL PORTION OF THAT DEVICE CRACKED AND HAD TO BE REPLACED. THE SURGEON, AND THE STRYKER SALES REP WHO WAS IN THE OPERATING ROOM AT THE TIME, SAID THEY HAD NEVER SEEN A FAILURE LIKE IT. DESPITE CLAIMS ON YOUR WEBSITE THAT YOUR KNEE REPLACEMENT DEVICES LAST 20 YEARS OR MORE, THE FEMORAL PORTION OF THE DEVICES IMPLANTED IN 2022 HAS NOW CRACKED AND I NEED YET ANOTHER SURGERY TO REPLACE IT. THAT WILL MAKE THREE SURGERIES IN A LITTLE OVER TEN YEARS -- THE LATEST LESS THAN FOUR YEARS AFTER THE LAST ONE -- TO IMPLANT THE SAME COMPONENTS THAT YOUR WEBSITE CLAIMS SHOULD LAST MUCH, MUCH LONGER. AS I'M SURE YOU'RE AWARE, NONE OF THESE SURGERIES ARE SIMPLE PROCEDURES. THEY'RE LONG AND INVOLVED AND REQUIR
Patient problems: Insufficient Information
MAUDE report 24627644 ↗InjuryFeb 16, 2026Fracture
PATIENT WAS BROUGHT TO SURGERY FOR A REVISION HER RIGHT GMRS PROXIMAL TIBIAL REPLACEMENT WITH MRH FEMUR. INITIAL SURGERY WAS DONE IN 2019. PATIENT STATED THAT APPROXIMATELY TWO WEEKS AGO SHE FELT A POP IN HER KNEE, THEN INSTANT INSTABILITY. THE DOCTOR THOUGHT SHE POSSIBLY BROKE THE AXLE IN THE HINGE COMPONENT. UPON DISSECTION, IT WAS NOTED THAT THE LATERAL FEMORAL CONDYLE HAD BROKEN OFF OF THE MRH FEMORAL COMPONENT. PATIENT HAD TO UNDERGO FULL REVISION OF THE FEMORAL COMPONENT WITH STEM. PATIENT WAS WALKING AND HEARD A ¿POP¿. NO EXTRANEOUS CAUSE WAS REPORTED.
Patient problems: Ambulation or Postural Difficulties
MAUDE report 24344326 ↗InjuryJan 28, 2026Adverse Event Without Identified Device or Use Problem
THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO SUSPECTED INFECTION. ALL COMPONENTS EXCEPT THE BASEPLATE, FEMORAL COMPONENT, WEDGE AND STEMS WERE REVISED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.
Patient problems: Unspecified Infection
MAUDE report 24203380 ↗InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem
THE FOLLOWING INFORMATION WAS PROVIDED: REVISION OF LEFT MRH, 2 STAGE, DUE TO LIKELY INFECTION.
Patient problems: Unspecified Infection
MAUDE report 24055187 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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