GMRSRecalls & reported problems across all models
Howmedica Osteonics Corp. · 32 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 114
- Deaths reported
- 0
- Injuries reported
- 101
- Recalls
- 0
We found 32 models of GMRS by Howmedica Osteonics Corp. in the FDA's device registry (GUDID). Together they are named in 114 adverse event reports in the FDA's MAUDE database, received between Jun 29, 2017 and Sep 9, 2026 — classified as 101 injuries, 13 malfunctions.
The most frequently reported specific device problem is “Loss of Osseointegration” (23 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 GMRS problems
Device problems
- Adverse Event Without Identified Device or Use Problem23
- Loss of Osseointegration23
- Insufficient Device Problem Information15
- Degraded13
- Mechanical Problem6
- Detachment of Device or Device Component5
- Device Dislodged or Dislocated5
- Fracture5
Patient problems
- Injury24
- Inadequate Osseointegration23
- Insufficient Information23
- Unspecified Infection14
- Ambulation or Postural Difficulties9
- Pain9
- No Consequences Or Impact To Patient7
- Joint Laxity5
GMRS models
32 models, most reported first. Each model has its own page with its reports, recalls and device details.
- GMRS 6495-2-040PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER15 reports
- GMRS 6495-2-010Prosthesis, hip, semi-constrained, metal/polymer, cemented13 reports
- GMRS 6495-2-020PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER10 reports
- GMRS 6495-2-030Prosthesis, hip, semi-constrained, metal/polymer, cemented7 reports
- GMRS 6495-1-001Prosthesis, hip, semi-constrained, metal/polymer, cemented5 reports
- GMRS 6495-2-105Prosthesis, hip, semi-constrained, metal/polymer, cemented5 reports
- GMRS 6495-6-040Prosthesis, hip, semi-constrained, metal/polymer, cemented5 reports
- GMRS 6495-6-080Prosthesis, hip, semi-constrained, metal/polymer, cemented5 reports
- GMRS 6495-3-010Prosthesis, hip, semi-constrained, metal/polymer, cemented4 reports
- GMRS 6495-3-102PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER4 reports
- GMRS 6495-5-011Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented3 reports
- GMRS 6495-1-201PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED3 reports
- GMRS 6495-2-115Prosthesis, hip, semi-constrained, metal/polymer, cemented3 reports
- GMRS 6495-3-016PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER3 reports
- GMRS 6495-3-101PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER3 reports
- GMRS 6495-6-030Prosthesis, hip, semi-constrained, metal/polymer, cemented3 reports
- GMRS 6495-5-012Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented2 reports
- GMRS 6495-1-002Prosthesis, hip, semi-constrained, metal/polymer, cemented2 reports
- GMRS 6495-6-070PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER2 reports
- GMRS 6495-6-120Prosthesis, hip, semi-constrained, metal/polymer, cemented2 reports
- GMRS 6495-6-050Prosthesis, hip, semi-constrained, metal/polymer, cemented2 reports
- GMRS 6497-1-150PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER2 reports
- GMRS 6497-1-600PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER2 reports
- GMRS 6495-5-013PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- GMRS 6495-5-211PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- GMRS 6495-5-215Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- GMRS 6495-5-219PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- GMRS 6495-3-601PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- GMRS 6495-6-019Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- GMRS 6495-6-060PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- GMRS 6495-6-140PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- GMRS 6497-1-580PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER1 report
Recent GMRS adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 9, 2026Degraded
It was reported that the patient presented with poly failure and wear as well as apparent metallosis of GMRS taper junctions which was noticed upon patella fracture treatment.
Patient problems: Foreign Body Reaction
MAUDE report 50690352 ↗InjurySep 9, 2026Degraded
It was reported that the patient presented with poly failure and wear as well as apparent metallosis of GMRS taper junctions which was noticed upon patella fracture treatment.
Patient problems: Foreign Body Reaction
MAUDE report 50690351 ↗InjuryAug 25, 2026Material Erosion
It was reported through the filing of a lawsuit that allegedly the patient was implanted with an LFIT Anatomic CoCr V40 Femoral Head on his left hip on or about (b)(6) 2014 and was revised on (b)(6) 2024. It is further alleged that he suffered injuries as a result of implantation and explantation of the device at issue, device recall, and excessive levels of cobalt and chromium in his blood.
Patient problems: Metal Related Pathology
MAUDE report 50436793 ↗InjuryAug 12, 2026Mechanical Problem
Patient problems: Insufficient Information
MAUDE report 50223064 ↗InjuryJun 24, 2026Degraded; Loss of Osseointegration
THE FOLLOWING INFORMATION WAS PROVIDED: THE PRIMARY PROCEDURE OF GMRS WAS DONE IN 2004. REVISION SURGERY WAS CARRIED OUT ON (B)(6) 2026 DUE TO SUSPECTED TIBIAL LOOSENING. HOWEVER, WHEN DR KC WONG OPEN THE JOINT CAPSULE, MASSIVE AND EXTENSIVE METALLOSIS WAS SEEN AROUND THE PROSTHESIS. WHEN WE TRY TO IMPACT A NEW 80MM EXTENSION PIECE, WE FOUND THAT THE MALE TAPER WAS MUCH LARGER THAN THE FEMALE TAPER OF THE EXT. PIECE. WE STRUGGLED THAT IF WE NEED TO REMOVE THE IN-SITU STEM SINCE WE HAD NO IDEA WHY THE TAPER LOOKED DIFFERENT. SOMEHOW A NURSING STAFF SUGGESTED THAT PART OF THE FEMALE TAPER OF THE IN-SITU 80MM EXT. PIECE MIGHT BE PEELED OFF AND COLDWELDED TO THE STEM'S MALE TAPER. THEREFORE THE SURGEONS TRIED TO USE METAL CUTTING DEVICE TO CUT A BIT ON THE TAPER. FINALLY WE MANAGED TO TAKE AWAY THE PEELED OFF PART AND EXPOSED THE ORIGINAL MALE TAPER OF THE STEM BUT IT EXTENDED THE SURGERY FOR ALMOST 3/4 HOURS. CONCLUSION IS THAT EXTENSION PIECE MIGHT HAVE A FAILURE TRUNNION.
Patient problems: Foreign Body Reaction; Inadequate Osseointegration; Insufficient Information
MAUDE report 25610317 ↗InjuryMay 19, 2026Adverse Event Without Identified Device or Use Problem
THE FOLLOWING INFORMATION WAS PROVIDED: REVISION OF GMRS DISTAL FEMORAL REPLACEMENT DUE TO FRACTURE OF THE PROXIMAL FEMUR.
Patient problems: Insufficient Information
MAUDE report 25225374 ↗InjuryMay 11, 2026Corroded
THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO PATIENT COMPLAINT OF PAIN AND SWELLING. INTRA-OPERATIVELY, SURGEON REPORTED CORROSION BETWEEN THE GMRS FEMORAL COMPONENT AND THE STEM. THE FEMORAL COMPONENT AND AXLE WERE REVISED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON. Q.
Patient problems: Metal Related Pathology; Pain; Swelling/ Edema
MAUDE report 25134399 ↗InjuryMay 7, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AFTER AN INTRA-OPERATIVE FRACTURE OF THE PATIENT'S LEFT FEMUR ONE DAY PRIOR, THE PATIENT WAS BROUGHT BACK (AS PLANNED) AND A COMPETITOR PLATE WAS IMPLANTED. NO IMPLANTS WERE REMOVED. CASE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.
Patient problems: Periprosthetic fracture
MAUDE report 25109740 ↗InjuryApr 20, 2026Unstable; Malposition of Device
THE FOLLOWING INFORMATION WAS PROVIDED: THIS PI IS FOR THE IMPENDING 2025 REVISION. AS PER PSS IMPLANT REQUEST CASE: CONVERSION OF STRYKER LEFT GMRS DISTAL FEMUR & PROXIMAL TIBIA TO A FIXED HINGE. USAGE STICKERS GIVEN FOR INITIAL ((B)(6) 2023) AND REVISION CASE ((B)(6) 2023) LEFT PROXIMAL TIBIA AND DISTAL FEMORAL GMRS IN-SITU, REQUIRES CONVERSION TO FIXED HINGE. LEAVING AS MUCH OF CURRENT IMPLANT IN-SITU. INITIAL IMPLANTATION OF PROXIMAL TIBIA GMRS AND DISTAL FEMORAL GMRS COMPLETED ON (B)(6) 2023 WITH 10MM TIBIAL INSERT, REVISED ON (B)(6) 2023 TO 16MM TIBIAL INSERT. A 30MM EXTENSION PIECE WAS USED, UNSURE ON WHETHER THIS WAS UTILISED ON FEMUR OR TIBIA, WILL CONFIRM ONCE IMAGING IS RECEIVED FROM SURGEON. UPDATE: THIS REVISION WAS BOOKED FOR PATELLA STABILIZATION. THE PATIENT HAS A CHRONICALLY SUBLUXING PATELLA DUE TO THE ROTATING HINGE COMPONENT OF THE PROSDASTHESIS. A PROSTHESIS WHICH LIMITS THE ROTATION RATHER THAN ELIMINATING IT WOULD BE ACCEPTABLE TOO. MI SESTIMATE THE PATELLA DISLOCATES WHEN THE TIBIA EXTERNALLY ROTATES¿ UPDATE 25/3/2026: COMPLETION OF CUSTOM PROXIMAL TIBIA REPLACEMENT AND REVISION. SUCCESSFUL COMPLETION OF SURGERY. SURGEON MODIFIED MRH AXLE 64812120 WITH CEMEN
Patient problems: Insufficient Information; Joint Laxity
MAUDE report 24933887 ↗InjuryMar 17, 2026Loss of Osseointegration
THE FOLLOWING INFORMATION WAS PROVIDED: THIS PI IS FOR THE 2021 REVISION: AS PER PSS CASE: LOOSENING RIGHT DISTAL TIBIA. 1ST SURGERY GMRS PROXIMAL TIBIA WITH CEMENTED STEM (B)(6) 2019. 2ND SURGERY LONGER EXTENSION WITH 17MM CEMENTLESS STEM (B)(6) 2021. REQUESTING CUSTOM MADE STEM. CEMENTLESS 7CM IN LENGTH. UPDATE: THIS PI IS FOR THE 2021 REVISION: AS PER PSS CASE: LOOSENING RIGHT PROXIMAL TIBIA STEM. 1ST SURGERY GMRS PROXIMAL TIBIA AND DISTAL FEMUR WITH CEMENTED STEMS (B)(6) 2019. 2ND SURGERY REVISION OF LOOSE CEMENTED FEMUR STEM WITH CEMENTLESS STEM (B)(6) 2021. REQUESTING CUSTOM MADE STEM. SHOT TIBIAL STEM CEMENTLESS 7CM IN LENGTH.
Patient problems: Inadequate Osseointegration
MAUDE report 24616798 ↗InjuryNov 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION OF KNEE WITH GMRS DISTAL FEMUR INSITU DUE TO SURGEON REPORT OF SYNOVITIS. SEVERAL COMPONENTS WERE REPLACED, BUT NO REPORT OF COMPONENT INVOLVEMENT.
Patient problems: Synovitis
MAUDE report 23454881 ↗InjuryOct 21, 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: LEFT GMRS WITH MULTIPLE QUAD RUPTURES WITH DIFFICULTY WITH CASTS AND BRACES AFTER REPAIR. REVISION SURGERY. ANTICIPATE CONVERTING BACK TO ROTATING HINGE IN ABOUT 3 MONTHS.
Patient problems: Insufficient Information
MAUDE report 23346350 ↗InjuryOct 20, 2025Loss of Osseointegration; Malposition of Device; Loss of Osseointegration; Malposition of Device
InjuryOct 20, 2025Degraded; Unstable; Degraded; Unstable
InjuryOct 20, 2025Degraded; Unstable; Degraded; Unstable
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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