FDA Adverse Event
Malfunction
Summary report: N
TRIDENT 0 X3 INSERT 36MM ID
MDR report key: 2020522
·
Received February 16, 2011
Report
- Report Number
- 9616680-2011-00071
- Event Type
- Malfunction
- Date Received
- February 16, 2011
- Date of Event
- January 31, 2011
- Report Date
- February 6, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- LZO
- PMA / PMN Number
- K061434
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
WHEN COMPLETED, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "DURING THE REVISION SURGERY, THE SURGEON FELT THAT THEY WERE LITTLE BIT TIGHT BETWEEN INSERT (STRYKER PRODUCT) AND CERAMIC HEAD (LIMA PRODUCT)."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIDENT 0 X3 INSERT 36MM ID | IMPLANT | LZO | STRYKER ORTHOPAEDICS CORK | NA | 33316701 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Other |