FDA Adverse Event
Injury
Summary report: N
UNKNOWN_RECONSTRUCTIVE_PRODUCT
MDR report key: 3243811
·
Received July 23, 2013
Report
- Report Number
- 0002249697-2013-02409
- Event Type
- Injury
- Date Received
- July 23, 2013
- Date of Event
- June 6, 2013
- Report Date
- June 7, 2013
- Manufacturer
- STRYKER ORTHOPAEDICS-MAHWAH
- Product Code
- JWH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
AN EVENT REGARDING DISLOCATION INVOLVING A LINER WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE EVALUATION COULD NOT BE PERFORMED AS NO ITEMS WERE RETURNED. DEVICE HISTORY REVIEW NOT PERFORMED AS NO DEVICE DETAILS WERE PROVIDE. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED.
Additional Manufacturer Narrative · 1
CATALOG NUMBER AND LOT CODE WERE NOT PROVIDED. THE DEVICE WAS REPORTED AS AN UNKNOWN INSERT. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
ON (B)(6) 2013, IT WAS CONFIRMED THAT AN UNKNOWN INSERT WAS REVISED DUE TO THE PATIENT EXPERIENCING TWO DISLOCATIONS.
Description of Event or Problem · 1
ON (B)(6) 2013, IT WAS CONFIRMED THAT AN UNKNOWN INSERT WAS REVISED DUE TO THE PATIENT EXPERIENCING TWO DISLOCATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 343837 | UNKNOWN_RECONSTRUCTIVE_PRODUCT | IMPLANT | JWH | STRYKER ORTHOPAEDICS-MAHWAH | STRYKER ORTHOPAEDICS-MAHWAH | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |