FDA Adverse Event
Injury
Summary report: N
TRABECULAR METAL ACETABULAR CUP, 28/54MM, 1
MDR report key: 2620585
·
Received June 13, 2012
Report
- Report Number
- 3005751028-2012-00079
- Event Type
- Injury
- Date Received
- June 13, 2012
- Date of Event
- June 6, 2011
- Report Date
- June 12, 2012
- Manufacturer
- ZIMMER TRABECULAR METAL TECHNOLOGY
- Product Code
- LPH
- PMA / PMN Number
- K964509
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IN PROCESS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT WAS REVISED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRABECULAR METAL ACETABULAR CUP, 28/54MM, 1 | TM MONOBLOCK CUP | LPH | ZIMMER TRABECULAR METAL TECHNOLOGY | 60811321 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Required Intervention |