FDA Adverse Event
Other
Summary report: N
LINEAGE TRANSCEND CERAMIC ACETABULAR LINER
MDR report key: 569910
·
Received January 31, 2005
Report
- Report Number
- 1043534-2005-00007
- Event Type
- Other
- Date Received
- January 31, 2005
- Date of Event
- October 27, 2004
- Report Date
- January 26, 2005
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- MRA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
PHYSICIAN HAMMERED CERAMIC ACETABULAR LINER INTO POSITION. LINER CRACKED AND HAD TO BE REMOVED. UPON REMOVAL IT SHATTERED INTO PIECES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LINEAGE TRANSCEND CERAMIC ACETABULAR LINER | HIP COMPONENT | MRA | WRIGHT MEDICAL TECHNOLOGY, INC. | NA | 03477947 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO | Other |