FDA Adverse Event
Injury
Summary report: N
TRIDENT 32 0 DEGREE LINER
MDR report key: 1932938
·
Received December 14, 2010
Report
- Report Number
- 2249697-2010-01735
- Event Type
- Injury
- Date Received
- December 14, 2010
- Date of Event
- November 17, 2010
- Report Date
- November 17, 2010
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- KWY
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, 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. ADDITIONAL INFO (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. IF ADDITIONAL INFO BECOMES AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "PT DISLOCATED. SURGEON IS NOT SUBMITTING RAYS."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIDENT 32 0 DEGREE LINER | IMPLANT | KWY | STRYKER ORTHOPAEDICS MAHWAH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Other| R |