FDA Adverse Event
Injury
Summary report: N
DURACON ANT CONS TIB INS 16MSM
MDR report key: 2221278
·
Received August 17, 2011
Report
- Report Number
- 2249697-2011-01207
- Event Type
- Injury
- Date Received
- August 17, 2011
- Date of Event
- July 25, 2011
- Report Date
- July 25, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- JWH
- PMA / PMN Number
- K915512
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "THE PATIENT WAS COMPLAINING OF PAIN. THE SURGEON SAID THE COLLATERALS WERE LOOSE. THE SURGEON TRAILED A THICKER POLY WHICH GAVE THE PATIENT BETTER STABILITY. THE SURGEON COMMENTED THAT THE POSTERIOR ASPECT OF THE POLY WAS VERY WORN. THE SURGEON ALSO COMMENTED ON DELAMINATION."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DURACON ANT CONS TIB INS 16MSM | INSTRUMENT | JWH | STRYKER ORTHOPAEDICS MAHWAH | NA | UFBZA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Required Intervention |