FDA Adverse Event
Injury
Summary report: N
TRIDENT PSL HA CLUSTER 50MM
MDR report key: 1901584
·
Received November 12, 2010
Report
- Report Number
- 2249697-2010-01539
- Event Type
- Injury
- Date Received
- November 12, 2010
- Date of Event
- October 6, 2010
- Report Date
- October 20, 2010
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- MEH
- PMA / PMN Number
- K983382
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "PUT A 40MM HEAD IN AND SHE WAS NOT COMPLAINT. SHE IS AN ALCOHOLIC AND SHE DISLOCATED. THE CUP SHOWED REMARKABLE WEAR ON THE SUPERIOR PART OF THE CUP AND THE NOTCH ENGAGEMENT FOR THE LINER INSERTION WERE COMPLETELY WORN AWAY."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIDENT PSL HA CLUSTER 50MM | IMPLANT | MEH | STRYKER ORTHOPAEDICS MAHWAH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Other| R |