UNKN JOURNEY BCS / JOURNEY II BCS KNEE
Report
- Report Number
- 1020279-2024-00855
- Event Type
- Injury
- Date Received
- April 30, 2024
- Report Date
- April 30, 2024
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- JWH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
EXEMPTION NUMBER WAS INCLUDED.
CORRECTED DATA: B5: NARRATIVE UPDATED. G2: REPORT SOURCE UPDATED TO 'LITERATURE'. H2: NOT A SUMMARY REPORT. 'RWD2300584' REMOVED FROM EXEMPTION NUMBER FIELD.
SUMMARY REPORT QUARTER: JANUARY 1, 2024, THROUGH MARCH 31, 2024. B3: ACTUAL DATE OF EVENT(S) IS UNKNOWN. DATE RANGE FOR REGISTRY REPORT INCLUDES ALL EVENTS FROM 2007 THROUGH 31 DECEMBER 2021. G3: THIS REPORT IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF PREVIOUSLY DOWNLOADED REGISTRY DATA THAT WAS ASSESSED FOR ADVERSE EVENT REPORTING ON 25 APRIL 2024. H3, H6: IT WAS REPORTED THAT FROM THE REGISTRY STUDY "ONLINE LROI ANNUAL REPORT 2022", 64 PATIENTS UNDERWENT A REVISION SURGERY DUE TO UNSPECIFIED REASONS AFTER A PRIMARY TKA WITH A JOURNEY II BCS TKA SYSTEM. PATIENTS' OUTCOMES ARE UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. JOINT ARTHROPLASTY DATA RANGES FROM 2007 TO 31 DECEMBER 2021. THIS COMPLAINT WAS OPENED BY SMITH+NEPHEW TO DOCUMENT A PATIENT COMPLICATION IDENTIFIED THROUGH A REVIEW OF THE "ONLINE LROI ANNUAL REPORT 2022" FROM THE NETHERLANDS THAT INCLUDES REFERENCE TO THE USE OF A SMITH+NEPHEW PRODUCT. THE REPORTED ISSUE(S) RELATE TO KNOWN INHERENT PROCEDURAL RISKS THAT ARE APPROPRIATELY DOCUMENTED IN OUR RISK FILES. SMITH+NEPHEW WILL CONTINUE TO MONITOR TRENDS IN ACCORDANCE WITH OUR POST-MARKET SURVEILLANCE PROCESS AND TAKE NECESSARY ACTION AS REQUIRED IF ANTICIPATED SEVERITY AND/OR OCCURRENCE RATES ARE EXCEEDED. SMITH+NEPHEW HAS NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY SPECIFICATIONS AT THE TIME OF MANUFACTURE. THE LIMITED NATURE OF REGISTRY DATA COUPLED WITH THE ANONYMITY OF CONTRIBUTING HEALTHCARE PROVIDERS PROHIBITS FURTHER FOLLOW-UP TO OBTAIN ADDITIONAL EVENT AND PATIENT INFORMATION OR RETURN OF THE REPORTER¿S DEVICE. BASED ON OUR REVIEW OF ALL CURRENTLY AVAILABLE INFORMATION, WE ARE UNABLE TO CONFIRM A RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE DEVICE OR IDENTIFY A DEFINITIVE ROOT CAUSE. HOWEVER, AS THE USE OF OUR PRODUCT CANNOT BE EXCLUDED AS A POTENTIAL CAUSE OR CONTRIBUTORY FACTOR TO THE REPORTED ISSUE, WE ARE CONSERVATIVELY SUBMITTING THIS REPORT IN ACCORDANCE WITH APPLICABLE REGULATIONS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THAT ALTERS THE CONCLUSIONS OF THIS REPORT, A FOLLOW-UP REPORT WILL BE SUBMITTED AS REQUIRED.
IT WAS REPORTED THAT FROM THE LITERATURE REPORT "ONLINE LROI ANNUAL REPORT 2022", 64 PATIENTS UNDERWENT A REVISION SURGERY DUE TO UNSPECIFIED REASONS AFTER A PRIMARY TKA WITH A JOURNEY II BCS TKA SYSTEM. PATIENTS' OUTCOMES ARE UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. THESE OUTCOMES WERE ACCOUNTED FROM 2007 TO 31 DECEMBER 2021. THE REPORT IS AVAILABLE AT: HTTPS://WWW.LROI-REPORT.NL/APP/UPLOADS/2022/11/PDF-LROI-ANNUAL-REPORT-2022.PDF.
IT WAS REPORTED THAT FROM THE REGISTRY STUDY "ONLINE LROI ANNUAL REPORT 2022", 64 PATIENTS UNDERWENT A REVISION SURGERY DUE TO UNSPECIFIED REASONS AFTER A PRIMARY TKA WITH A JOURNEY II BCS TKA SYSTEM. PATIENTS' OUTCOMES ARE UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. JOINT ARTHROPLASTY DATA RANGES FROM 2007 TO 31 DECEMBER 2021.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 147789 | UNKN JOURNEY BCS / JOURNEY II BCS KNEE | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL | JWH | SMITH & NEPHEW, INC. | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Unknown | Hospitalization| R |