DuraconRecalls & reported problems across all models
Howmedica Osteonics Corp. · 58 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
16 open recalls name at least one Duracon model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 65
- Deaths reported
- 0
- Injuries reported
- 63
- Recalls
- 16
We found 58 models of Duracon by Howmedica Osteonics Corp. in the FDA's device registry (GUDID). Together they are named in 65 adverse event reports in the FDA's MAUDE database, received between May 24, 2018 and Apr 7, 2026 — classified as 63 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (20 reports).
16 FDA recall records name at least one of these models by its device identifier, 16 still open.
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
Duracon recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Dec 1, 2023Open, Classified
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
Z-0925-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
- Dec 1, 2023Open, Classified
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
Z-0924-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
- Dec 1, 2023Open, Classified
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
Z-0923-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
- Dec 1, 2023Open, Classified
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
Z-0918-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
- Dec 1, 2023Open, Classified
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
Z-0917-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
- Dec 1, 2023Open, Classified
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
Z-0916-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
- Dec 1, 2023Open, Classified
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
Z-0915-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
- Dec 1, 2023Open, Classified
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
Z-0914-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
- Dec 1, 2023Open, Classified
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
Z-0913-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
- Dec 1, 2023Open, Classified
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
Z-0912-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
- Dec 1, 2023Open, Classified
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
Z-0911-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
- Dec 1, 2023Open, Classified
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
Z-0910-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
- Dec 1, 2023Open, Classified
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
Z-0909-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
- Dec 1, 2023Open, Classified
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
Z-0908-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
- Dec 1, 2023Open, Classified
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
Z-0907-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
- Dec 1, 2023Open, Classified
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
Z-0906-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Most reported Duracon problems
Device problems
- Fracture20
- Loss of Osseointegration16
- Insufficient Device Problem Information8
- Detachment of Device or Device Component7
- Adverse Event Without Identified Device or Use Problem5
- Break5
- Unstable5
- Osseointegration Problem4
Patient problems
- Injury29
- Inadequate Osseointegration17
- Ambulation or Postural Difficulties13
- Pain11
- Insufficient Information9
- Unspecified Infection7
- Bone Fracture(s)4
- Inflammation4
Duracon models
58 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Duracon 6637-0-028PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall0 reports
- Duracon 6637-0-228PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall0 reports
- Duracon 6637-0-231PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall0 reports
- Duracon 6637-0-328PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall0 reports
- Duracon 6637-0-631PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall0 reports
- Duracon 6637-0-831PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall0 reports
- Duracon 6637-0-928PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall0 reports
- Duracon 6637-0-931PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall0 reports
- Duracon 6637-4-031PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall0 reports
- Duracon 6637-4-231PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall0 reports
- Duracon 6642-1-709PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall0 reports
- Duracon 6642-1-911PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall0 reports
- Duracon 6642-2-200PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 recall0 reports
- Duracon 6742-1-411PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall0 reports
- Duracon 6742-1-413PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall0 reports
- Duracon 6742-1-416PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall0 reports
- Duracon 6478-6-665PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER6 reports
- Duracon 6478-6-620PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER3 reports
- Duracon 6478-6-640PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER3 reports
- Duracon 6478-6-685PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER3 reports
- Duracon 6478-6-710PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER3 reports
- Duracon 6478-6-715PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER3 reports
- Duracon 6478-6-720PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER3 reports
- Duracon 6478-6-438PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- Duracon 6478-6-600PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- Duracon 6478-6-615PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- Duracon 6478-6-625PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- Duracon 6478-6-695PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- Duracon 6478-6-740PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- Duracon 6642-1-611PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- Duracon 6642-1-613PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- Duracon 6642-1-625PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 report
- Duracon 6642-1-711PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 report
- Duracon 6642-1-713PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 report
- Duracon 6642-1-809PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 report
- Duracon 6642-1-811PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 report
- Duracon 6642-1-909PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 report
- Duracon 6642-5-311PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- Duracon 6642-9-613PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- Duracon 6642-9-616Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- Duracon 6742-1-309PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- Duracon 6742-1-311PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- Duracon 6642-2-626PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- Duracon 6632-3-615PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- Duracon 6478-6-400PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- Duracon 6478-6-405PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- Duracon 6478-6-440PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- Duracon 6478-6-610PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- Duracon 6478-6-630PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- Duracon 6478-6-645PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- Duracon 6478-6-655PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- Duracon 6478-6-690PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- Duracon 6478-6-705PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- Duracon 6478-6-725PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- Duracon 6478-6-730PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- Duracon 6742-4-209PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- Duracon 6742-4-222PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 report
- Duracon 6478-6-490PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER1 report
Recent Duracon adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryApr 7, 2026Degraded
THE FOLLOWING INFORMATION WAS PROVIDED: SURGEON REVISED DURACON POLY INSERT & FOUND POSTERIOR CORNERS WERE WORN SIGNIFICANTLY. WEAR WAS NOTED TO POSTERIOR BASE PLATE.
Patient problems: Insufficient Information
MAUDE report 24800402 ↗InjuryAug 6, 2025Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem; Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem
INFORMATION RECEIVED FROM (B)(4) INDICATES THE FOLLOWING: R TOTAL KNEE REVISION FOR PATELLAR DISPLACEMENT ON (B)(6) 2014. ALL COMPONENTS REMOVED. ALSO HAD IPSILATERAL ANKLE FRACTURE BETWEEN GMRS SURGERY AND LAST F/U VISIT WHERE FEMORAL STEM LOOSENING WAS DIAGNOSED. DECLINED DISCUSSION OF SURGERY AT LAST VISIT. HAD ORDER FOR PT AND PLAN WAS TO CONTINUE W THIS.
Patient problems: Bone Fracture(s); Joint Dislocation
MAUDE report 22733554 ↗InjuryAug 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS PI IS FOR THE WOUND INFECTION. INFORMATION RECEIVED FROM (B)(4) INDICATES THE FOLLOWING: WOUND INFECTION SUSPECTED (B)(6) 2013, IV VANC, NO RETURN TO OR. LATER NEEDED TO BE ON LIFELONG ORAL ANTIBIOTICS FOR CHRONIC SUPPRESION.
Patient problems: Unspecified Infection
MAUDE report 22724384 ↗InjuryAug 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS PI IS FOR THE STAGE 1 REVISION DUE TO INFECTION. INFORMATION RECEIVED FROM (B)(4) INDICATES THE FOLLOWING: ON (B)(6) 2015 HAD A FRACTURE ON FEMUR SIDE REQUIRING ORIF WHICH GOT INFECTED. ENTIRE FEMORAL AND TIBIAL COMPONENT REMOVED AND SPACER PLACED (B)(6) 2015. LEFT KNEE.
Patient problems: Unspecified Infection
MAUDE report 22724338 ↗InjuryAug 5, 2025Loss of Osseointegration; Loss of Osseointegration
INFORMATION RECEIVED FROM IIS 2023-001 INDICATES THE FOLLOWING: ASEPTIC LOOSENING. TIBIAL COMPONENTS REVISED. LEFT KNEE.
Patient problems: Inadequate Osseointegration
MAUDE report 22720195 ↗InjuryAug 5, 2025Loss of Osseointegration; Loss of Osseointegration
INFORMATION RECEIVED FROM (B)(4) INDICATES THE FOLLOWING: ASEPTIC LOOSENING. ALL COMPONENTS REMOVED. LEFT KNEE.
Patient problems: Inadequate Osseointegration
MAUDE report 22720191 ↗InjuryAug 5, 2025Loss of Osseointegration; Loss of Osseointegration
INFORMATION RECEIVED FROM IIS 2023-001 INDICATES THE FOLLOWING: ASEPTIC LOOSENING. ALL COMPONENTS REMOVED. LEFT KNEE.
Patient problems: Inadequate Osseointegration
MAUDE report 22719999 ↗InjuryAug 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
INFORMATION RECEIVED FROM IIS 2023-001 INDICATES THE FOLLOWING: PROSTHETIC JOINT INFECTION REQUIRED I&D. NO COMPONENTS WERE REMOVED. RIGHT KNEE.
Patient problems: Unspecified Infection
MAUDE report 22713686 ↗InjuryAug 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
INFORMATION RECEIVED FROM (B)(4) INDICATES THE FOLLOWING: PROSTHETIC JOINT INFECTION REQUIRED I&D. NO COMPONENTS WERE REMOVED. RIGHT KNEE.
Patient problems: Unspecified Infection
MAUDE report 22713668 ↗InjuryJul 31, 2025Loss of Osseointegration; Loss of Osseointegration
THE FOLLOWING WAS REPORTED: "ASEPTIC LOOSENING. ALL COMPONENTS REMOVED. LEFT KNEE."
Patient problems: Inadequate Osseointegration
MAUDE report 22680395 ↗InjuryJul 31, 2025Loss of Osseointegration; Loss of Osseointegration
INFORMATION RECEIVED FROM IIS 2023-001 INDICATES THE FOLLOWING: R DISTAL 1/3RD TIBIA FRACTURE. CLOSED REDUCTION AND CASTING UNDER MAC ANAESTHESIA. ALSO HAD IPSILATERAL ANKLE FRACTURE BETWEEN GMRS SURGERY AND LAST F/U VISIT WHERE FEMORAL STEM LOOSENING WAS DIAGNOSED. DECLINED DISCUSSION OF SURGERY AT LAST VISIT. HAD ORDER FOR PT AND PLAN WAS TO CONTINUE W THIS.
Patient problems: Bone Fracture(s)
MAUDE report 22673410 ↗InjuryJul 31, 2025Loss of Osseointegration; Loss of Osseointegration
INFORMATION RECEIVED FROM (B)(4) INDICATES THE FOLLOWING: FEMORAL STEM LOOSENING. REQUIRED REVISION ON OF THE R SIDE.
Patient problems: Inadequate Osseointegration
MAUDE report 22673408 ↗InjuryJul 30, 2025Fracture; Fracture
INFORMATION RECEIVED FROM IIS 2023-001 INDICATES THE FOLLOWING: BROKEN TIBIAL STEM. TIBIAL COMPONENTS REMOVED. RIGHT KNEE.
Patient problems: Insufficient Information
MAUDE report 22663182 ↗InjuryJul 9, 2025Loss of Osseointegration; Loss of Osseointegration
REVISION OF MRH FEMUR WITH PRESS-FIT STEM, FOUND LOOSE.
Patient problems: Inadequate Osseointegration
MAUDE report 22459268 ↗InjuryJan 6, 2025Degraded; Fracture; Detachment of Device or Device Component; Osseointegration Problem; Degraded; Fracture; Detachment of Device or Device Component; Osseointegration Problem
STEM-GUIDED CTEP: FATIGUE OF THE FEMORAL COUPLING SITE BETWEEN THE STEM AND FEMORAL IMPLANT. SIGNIFICANT METALLOSIS IN THE JOINT, THE COUPLING POINT BETWEEN THE STEM AND THE FEMORAL COMPONENT IS CLEARLY LOOSENED. AXIAL DEVIATION AND ROTATIONAL INSTABILITY OF APPROX. 15 DEGREES THE FEMORAL COMPONENT CAN BE SALVAGED IN CONJUNCTION WITH THE STEM (OP ENDOGAP (B)(6) 2024). THE IMPLANT WAS TRANSFERRED TO THE PATIENT AT THE PATIENT'S REQUEST.
Patient problems: Inadequate Osseointegration; Joint Laxity; Metal Related Pathology
MAUDE report 21080569 ↗
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
- LFIT23 models · 852 reports
- TRIDENT II42 models · 188 reports · 12 recalls
- INSTRUMENT131 models · 290 reports · 7 recalls
- EXETER36 models · 344 reports · 3 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.
How reports and recalls are matched · Editorial policy · Report an error on this page