LINKSYMPHOKNEE
Report
- Report Number
- 3004371426-2025-00006
- Event Type
- Malfunction
- Date Received
- February 14, 2025
- Date of Event
- October 31, 2024
- Report Date
- October 31, 2024
- Manufacturer
- WALDEMAR LINK GMBH & CO. KG
- Product Code
- HRY
- PMA / PMN Number
- K202924
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- 003
Narratives
THE DEVICE HISTORY RECORDS WERE VIEWED. DUE TO THE INITIATED RECALL, THE COMPLAINT WAS RETROSPECTIVELY CLASSIFIED AS REPORTABLE.
THE REVIEW OF THE DEVICE HISTORY RECORD SHOWED NO DEVIATIONS. THIS IS THE FINAL SUPPLEMENTAL REPORT. THE COMPLAINT IS CLOSED.
CN NOTIFIED WL OF A POTENTIAL ERROR ON THE GTIN NUMBER PROVIDED IN THE RECEIVING PAPERWORK FOR ARTICLE 880-601/12 ON OCT 31, 2024, NOTICED WHILE SCANNING THE PACKAGE LABEL. LINK NOTIFIED LINKBIO ON DEC 4, 2024 THAT THE GTIN NUMBER HAD BEEN CHANGED AND THAT A COMPLAINT WAS INITIATED TO INVESTIGATE THE ISSUE. FURTHER, A REVIEW OF THE GUDID DATABASE FOLLOWING THIS NOTIFICATION INDICATED THAT PRODUCT HAD NOT BEEN UPDATED IN THE GUDID DATABASE WITH THE NEW GTIN NUMBER. [CUSTOMER].
CN NOTIFIED WL OF A POTENTIAL ERROR ON THE GTIN NUMBER PROVIDED IN THE RECEIVING PAPERWORK FOR ARTICLE 880-601/12 ON OCT 31, 2024, NOTICED WHILE SCANNING THE PACKAGE LABEL. LINK NOTIFIED LINKBIO ON DEC 4, 2024 THAT THE GTIN NUMBER HAD BEEN CHANGED AND THAT A COMPLAINT WAS INITIATED TO INVESTIGATE THE ISSUE. FURTHER, A REVIEW OF THE GUDID DATABASE FOLLOWING THIS NOTIFICATION INDICATED THAT PRODUCT HAD NOT BEEN UPDATED IN THE GUDID DATABASE WITH THE NEW GTIN NUMBER. [CUSTOMER].
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1204953 | LINKSYMPHOKNEE | MODULAR STEM CYLINDRICAL, TILASTAN, PRESS-FIT CEMENTLESS, L= 80 MM, PRODUCT CODE | HRY | WALDEMAR LINK GMBH & CO. KG | 880-601/12 | 1943276 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |