FDA Adverse Event
Malfunction
Summary report: N
MOBILELINK ACETABULAR CUP SYSTEM
MDR report key: 21421792
·
Received February 20, 2025
Report
- Report Number
- 3004371426-2025-00007
- Event Type
- Malfunction
- Date Received
- February 20, 2025
- Date of Event
- January 28, 2025
- Report Date
- February 3, 2025
- Manufacturer
- WALDEMAR LINK GMBH & CO. KG
- Product Code
- LPH
- UDI-DI
- 04026575177035
- PMA / PMN Number
- K182321
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- 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. CORRECTION OF PMA/510(K): K182321.
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
POLY INSERT DID NOT ENGAGE.
Description of Event or Problem · 0
POLY INSERT DID NOT ENGAGE. [CUSTOMER].
Description of Event or Problem · 0
POLY INSERT DID NOT ENGAGE. [CUSTOMER].
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 464510 | MOBILELINK ACETABULAR CUP SYSTEM | INSERT, X-LINKED VIT-E PE, I.D.= 36MM, INSERT SIZE C, NEUTRAL, | LPH | WALDEMAR LINK GMBH & CO. KG | 183-362/36 | 2443156 | 04026575177035 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Unknown |