FDA Adverse Event
Malfunction
Summary report: N
TRIDENT PSL HA CLUSTER 54MM
MDR report key: 2110176
·
Received May 19, 2011
Report
- Report Number
- 2249697-2011-00749
- Event Type
- Malfunction
- Date Received
- May 19, 2011
- Date of Event
- April 27, 2011
- Report Date
- April 27, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- MEH
- PMA / PMN Number
- K983382
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
YOUNG FEMALE WITH VERY HARD BONE. REAMED ACETABULUM TO 55MM AND IMPLANTED A 54MM TRIDENT PSL CUP. CUP DEFORMED UPON IMPACTION WHICH RESULTED IN THE CERAMIC LINER TOGGLING ON THE CUP RIM PRIOR TO IMPACTION. UNABLE TO SEAT THE LINER DUE TO CUP DEFORMATION. REMOVED LINER AND IMPLANTED A POLY LINER. ANOTHER ITEM WAS USED INSTEAD AND CASE COMPLETED AS ORIGINALLY PLANNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIDENT PSL HA CLUSTER 54MM | IMPLANT | MEH | STRYKER ORTHOPAEDICS MAHWAH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |