FDA Adverse Event
Injury
Summary report: N
TRIDENT PSL CUP
MDR report key: 1855139
·
Received September 30, 2010
Report
- Report Number
- 2249697-2010-01300
- Event Type
- Injury
- Date Received
- September 30, 2010
- Date of Event
- January 4, 2007
- Report Date
- August 10, 2010
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- MEH
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INFO FOR THIS PER WAS PROVIDED BY STRYKER ORTHOPAEDICS CLINICAL AFFAIRS DEPARTMENT. NO ADDITIONAL INFO IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFO BECOMES AVAILABLE, THEN IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
THIS IS A RETROSPECTIVE (B)(4) STUDY. SITES ARE ONLY REQUIRED TO REPORT PER THEIR MILESTONES AS SIGNIFICANT AMOUNT OF TIME AFTER REVISIONS OCCURRED, AND THEREFORE WE DO NOT KNOW IF THE DEVICE WILL BE AVAILABLE. INITIAL SURGERY DATE (B)(6) 2007, REVISION DATE NOT PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIDENT PSL CUP | IMPLANT | MEH | STRYKER ORTHOPAEDICS MAHWAH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Other| R |