FDA Adverse Event
Injury
Summary report: N
CENTRAX DURATION 26MM X 51MM
MDR report key: 1060372
·
Received June 11, 2008
Report
- Report Number
- 2249697-2008-00167
- Event Type
- Injury
- Date Received
- June 11, 2008
- Date of Event
- May 9, 2008
- Report Date
- May 15, 2008
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- JDI
- PMA / PMN Number
- K972792
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFO HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "THE PT IS A CEREBRAL INFARCTION PT. HIS ENTIRE LEFT SIDE WAS PARALYZED BEFORE PRIMARY SURGERY. THE PT RECEIVED A PRIMARY BHA SURGERY IN 2007. AFTERWARD, THE PT EXPERIENCED DISLOCATION IN 2008, AND FOUR MONTHS LATER, DUE TO FALLING. THE SURGEON SUCCEEDED IN CLOSED REDUCTION THE FIRST TIME OF THE DISLOCATION, BUT WAS UNSUCCESSFUL THE SECOND TIME. DURING THE CLOSE REDUCTION, THE HEAD CAME OFF FROM OUTER CUP. THEN, THE PT RECEIVED A REVISION SURGERY THE NEXT DAY. DURING THE SURGERY, THE SURGEON REALIZED THAT THE LOCKING RING HAD COME OFF FROM OUTER CUP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CENTRAX DURATION 26MM X 51MM | IMPLANT | JDI | STRYKER ORTHOPAEDICS MAHWAH | NA | A07C522 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Required Intervention |