FDA Adverse Event
Malfunction
Summary report: N
TRIDENT PSL HA CLUSTER 52MM
MDR report key: 1225302
·
Received November 4, 2008
Report
- Report Number
- 2249697-2008-00342
- Event Type
- Malfunction
- Date Received
- November 4, 2008
- Date of Event
- October 9, 2008
- Report Date
- October 9, 2008
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- MEH
- PMA / PMN Number
- K983382
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THERE IS INSUFFICIENT INFORMATION AT THIS TIME TO DETERMINE IF A STRYKER DEVICE CAUSED AN ADVERSE CONSEQUENCE FOR THE PATIENT. THE INFORMATION ON THIS PER WAS PROVIDED BY STRYKER ORTHOPAEDICS LEGAL AFFAIRS DEPARTMENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. AS PER THE INFORMATION RECEIVED, THE DEVICES ARE NOT AVAILABLE AT THE TIME OF THE PER DUE TO THE ONGOING LITIGATION. SHOULD DEVICE BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "THE PATIENT ALLEGES FAILURE OF HER HIP PROSTHESIS."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIDENT PSL HA CLUSTER 52MM | IMPLANT | MEH | STRYKER ORTHOPAEDICS MAHWAH | NA | 30853907 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Other |