FDA Adverse Event
Injury
Summary report: N
TRIDENT PSL HA CLUSTER 52MM
MDR report key: 2355879
·
Received November 23, 2011
Report
- Report Number
- 2249697-2011-01676
- Event Type
- Injury
- Date Received
- November 23, 2011
- Date of Event
- November 1, 2011
- Report Date
- November 1, 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
- ND, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
IF ADDITIONAL INFORMATION BECOMES AVAILABLE THEN IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT: CAT# 623-10-36E, LOT# MJKN36, DESCRIPTION: TRIDENT 10 X3 INSERT 36MM ID; CAT # 2030-6525-1, LOT # MJKY78, DESCRIPTION: 6.5 CANCELLOUS BONE SCREW 25MM; CAT # 18-3605, LOT # 33069901, DESCRIPTION: DELTA C-TAPER HEAD 36MM +5. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S PAIN.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "THE PATIENT HAD PAIN."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIDENT PSL HA CLUSTER 52MM | IMPLANT | LPH | STRYKER ORTHOPAEDICS MAHWAH | NA | MJD7YL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Other| R |