FDA Adverse Event
Injury
Summary report: N
TRIDENT PSL HA CLUSTER 48MM
MDR report key: 1802558
·
Received August 10, 2010
Report
- Report Number
- 2249697-2010-01077
- Event Type
- Injury
- Date Received
- August 10, 2010
- Date of Event
- July 16, 2010
- Report Date
- July 17, 2010
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- LPH
- PMA / PMN Number
- K983502
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, 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. THE X-RAYS AND MEDICAL RECORDS WERE REQUESTED, BUT NOT PROVIDED. IF ADDITIONAL INFO BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "CUP WAS LOOSE, PT HAD GROIN PAIN, CUP WAS NOT INGROWN. PRIMARY CUP APPEARED UNDER SIZED."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIDENT PSL HA CLUSTER 48MM | IMPLANT | LPH | STRYKER ORTHOPAEDICS MAHWAH | NA | N4VMKD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Other| R |