FDA Adverse Event
Injury
Summary report: N
TRIDENT PSL HA CLUSTER 54MM
MDR report key: 2233992
·
Received August 31, 2011
Report
- Report Number
- 2249697-2011-01298
- Event Type
- Injury
- Date Received
- August 31, 2011
- Date of Event
- August 15, 2011
- Report Date
- August 15, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- LPH
- PMA / PMN Number
- K983502
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. 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: "CUP WAS LOOSE SO SURGEON REMOVED CUP LINER, SCREWS AND REPLACED WITH A RESTORATION CUP TS CAGE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIDENT PSL HA CLUSTER 54MM | IMPLANT | LPH | STRYKER ORTHOPAEDICS MAHWAH | NA | MJKHNJ |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Other| R |