FDA Adverse Event
Malfunction
Summary report: N
PLASMACUP SC PLASMAPORE-¿CAP SIZE 54MM
MDR report key: 6051736
·
Received October 24, 2016
Report
- Report Number
- 3005673311-2016-00173
- Event Type
- Malfunction
- Date Received
- October 24, 2016
- Date of Event
- September 21, 2016
- Report Date
- January 6, 2017
- Manufacturer
- AESCULAP IMPLANT SYSTEMS
- Product Code
- MEH
- PMA / PMN Number
- K060437
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.
Additional Manufacturer Narrative · 1
ITEM NUMBER ORIGINALLY REPORTED WAS NOT MARKETED IN THE U.S.; THEREFORE, MED WATCH SUBMISSIONS IS NOT REQUIRED.
Description of Event or Problem · 1
COUNTRY OF COMPLAINT: (B)(6). IT WAS REPORTED THAT AFTER A 2008 IMPLANT OF A TOTAL ENDOPROSTHESES, THE PATIENT FRACTURED THEIR HIP, AND BROKE THE INSET CERAMIC INLAYS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 702219 | PLASMACUP SC PLASMAPORE-¿CAP SIZE 54MM | HIP ENDOPROSTHETICS | MEH | AESCULAP IMPLANT SYSTEMS | NC454T |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Other| R |