FDA Adverse Event
Injury
Summary report: N
UNKNOWN TRIDENT CUP
MDR report key: 2893432
·
Received December 21, 2012
Report
- Report Number
- 2249697-2012-02767
- Event Type
- Injury
- Date Received
- December 21, 2012
- Date of Event
- December 5, 2012
- Report Date
- November 28, 2012
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- LPH
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT METALLOSIS AT JUNCTURE OF THE ACETABULUM - CUP NEVER RECEIVED BONE INGROWTH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN TRIDENT CUP | IMPLANT | LPH | STRYKER ORTHOPAEDICS MAHWAH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other| R |