FDA Adverse Event
Malfunction
Summary report: N
VARIO-CUP
MDR report key: 22200447
·
Received June 13, 2025
Report
- Report Number
- 3004371426-2025-00025
- Event Type
- Malfunction
- Date Received
- June 13, 2025
- Date of Event
- May 20, 2025
- Report Date
- May 20, 2025
- Manufacturer
- WALDEMAR LINK GMBH & CO. KG
- Product Code
- KWY
- UDI-DI
- 04026575328314
- PMA / PMN Number
- K781735
- Product Problem
- 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.
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. CORRECTION OF PMA/510(K): K781735.
Description of Event or Problem · 0
AN EXPIRED PROSTHESES HAS BEEN IMPLANTED. [CUSTOMER].
Description of Event or Problem · 0
AN EXPIRED PROSTHESES HAS BEEN IMPLANTED. [CUSTOMER].
Description of Event or Problem · 0
AN EXPIRED PROSTHESES HAS BEEN IMPLANTED. [CUSTOMER].
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 341933 | VARIO-CUP | VARIO-CUP,50MM O.D.,F. HEAD DIA. 28 MM,WITH SAFETY RING,SELF-CENTERING | KWY | WALDEMAR LINK GMBH & CO. KG | 107-220/50 | 04026575328314 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |