FDA Adverse Event
Injury
Summary report: N
TRIDENT PSL HA CLUSTER 50MM
MDR report key: 2190424
·
Received July 28, 2011
Report
- Report Number
- 9616680-2011-00497
- Event Type
- Injury
- Date Received
- July 28, 2011
- Date of Event
- July 7, 2011
- Report Date
- July 7, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- LPH
- PMA / PMN Number
- K98382
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR. NO FURTHER INFO IS AVAILABLE. IF ADD'L INFO BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "ACETABULUM WAS LOOSE UPON INSPECTION. STEM WAS SOLID, PROCEEDED TO REVISED SHELL WITH A 40MM HEAD AND LINER."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIDENT PSL HA CLUSTER 50MM | IMPLANT | LPH | STRYKER ORTHOPAEDICS CORK | NA | 32343601 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Required Intervention |