FDA Adverse Event
Injury
Summary report: N
ENDO-MODEL SL KNEE JOINT PROSTHESIS
MDR report key: 21301411
·
Received February 4, 2025
Report
- Report Number
- 3004371426-2025-00002
- Event Type
- Injury
- Date Received
- February 4, 2025
- Date of Event
- January 1, 2025
- Report Date
- January 20, 2025
- Manufacturer
- WALDEMAR LINK GMBH & CO.KG
- Product Code
- KRO
- UDI-DI
- 04026575359240
- PMA / PMN Number
- K151008
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
THE REVIEW OF THE DEVICE HISTORY RECORD SHOWED NO DEVIATIONS. THE PRODUCT COMPLIES WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURE.
Additional Manufacturer Narrative · 0
THE REVIEW OF THE DEVICE HISTORY RECORD SHOWED NO DEVIATIONS. THE PRODUCT COMPLIES WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURE. THIS IS THE FINAL SUPPLEMENTAL REPORT, THE COMPLAINT IS CLOSED.
Description of Event or Problem · 0
JOINT INSTABILITY IN REVISION - MEGA SYSTEM C DX.[CUSTOMER]
Description of Event or Problem · 0
JOINT INSTABILITY IN REVISION - MEGA SYSTEM C DX. [CUSTOMER].
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1159262 | ENDO-MODEL SL KNEE JOINT PROSTHESIS | CONNECTION COMPONENTROTATIONAL VERSION,MEDIUM | KRO | WALDEMAR LINK GMBH & CO.KG | 16-2840/05 | 04026575359240 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |