FDA Adverse Event
Injury
Summary report: N
TRIDENT ACETABULAR SYSTEM
MDR report key: 2062743
·
Received April 13, 2011
Report
- Report Number
- 2249697-2011-00457
- Event Type
- Injury
- Date Received
- April 13, 2011
- Date of Event
- May 21, 2005
- Report Date
- March 18, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- LPH
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION ON THIS PER WAS PROVIDED BY STRYKER ORTHOPAEDICS LEGAL AFFAIRS DEPARTMENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. AS PER INFORMATION RECEIVED, THE DEVICES ARE NOT AVAILABLE AT THE TIME OF THE PER DUE TO THE ONGOING LITIGATION. ADDITIONAL FOLLOW-UP INFORMATION MAY BE OBTAINED BY THE LEGAL AFFAIRS AS IT BECOMES AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED THAT: "IT WAS REPORTED THROUGH THE ATTORNEY FOR THE PATIENT, AS A RESULT OF A LEGAL CLAIM, THAT ALLEGEDLY THE PATIENT RECEIVED A TRIDENT ACETABULAR HIP SYSTEM. IT WAS FURTHER ALLEGED THAT, THE PATIENT IS EXPERIENCING PAIN AND DISCOMFORT AND HAS SUFFERED SIX DISLOCATIONS AND HAS UNDERGONE FOUR REVISION SURGERIES."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIDENT ACETABULAR SYSTEM | IMPLANT | LPH | STRYKER ORTHOPAEDICS MAHWAH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other| R |