Kinematic 6485-2-108Recalls & reported problems
Howmedica Osteonics Corp. · Rotating Hinge Knee · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327047479), received between Aug 5, 2025 and Aug 5, 2025 — classified as 3 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).
4 other recalls cover devices cleared under the same FDA submission (K001548, K223069, K972863); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Insufficient Device Problem Information1
- Loss of Osseointegration1
Patient problems
- Bone Fracture(s)1
- Inadequate Osseointegration1
- Swelling/ Edema1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
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: PERIPROSTHETIC TIBIAL FRACTURE. TIBIAL COMPONENTS REVISED. RIGHT KNEE.
Patient problems: Bone Fracture(s)
MAUDE report 22719996 ↗InjuryAug 5, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
INFORMATION RECEIVED FROM IIS 2023-001 INDICATES THE FOLLOWING: OTHER MECHANICAL FAILURE (PSEUDOCAPSULE AND RECURRENT EFFUSION). ALL COMPONENTS REMOVED. RIGHT KNEE.
Patient problems: Swelling/ Edema
MAUDE report 22717829 ↗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 22713680 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K001548, K223069, K972863. One submission often covers many models, so check the product and lot details in each record.
- Z-0920-2024 · Dec 1, 2023 · Open, ClassifiedDUR PCA MTK REV INS LFT Intended for knee replacement Product Number: 6728-2-611
- Z-0919-2024 · Dec 1, 2023 · Open, ClassifiedDUR PCA MTK REV INS LFT Intended for knee replacement Product Number: 6728-2-609
- Z-0922-2024 · Dec 1, 2023 · Open, ClassifiedDUR PCA MTK REV INS RT Intended for knee replacement Product Number: 6728-2-711
- Z-0921-2024 · Dec 1, 2023 · Open, ClassifiedDUR PCA MTK REV INS RT Intended for knee replacement Product Number: 6728-2-709
Other PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER devices
- ATTUNE 1506-00-005Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER589 reports
- ATTUNE 1506-00-004Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER580 reports
- JOURNEY 74012812Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER502 reports
- JOURNEY 74011856Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER438 reports
- PERSONA™ 42-5099-094-00Zimmer, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER406 reports
- JOURNEY 74011857Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER388 reports
- ATTUNE 1506-00-007Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER288 reports
- ATTUNE 1506-00-003Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER271 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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