FDA Adverse Event
Injury
Summary report: N
PINN LNR CON +4 NEUT 32IDX54OD
MDR report key: 1241040
·
Received November 19, 2008
Report
- Report Number
- 1818910-2008-05366
- Event Type
- Injury
- Date Received
- November 19, 2008
- Date of Event
- October 28, 2008
- Report Date
- October 28, 2008
- Manufacturer
- DEPUY ORTHOPAEDICS, INC
- Product Code
- KWZ
- PMA / PMN Number
- K043058
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EXAMINATION WAS NOT POSSIBLE, AS THE DEVICE WAS NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT CODE SINCE ITS RELEASE FOR DISTRIBUTION. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT ERROR WITH REGARD TO THE REPORTED EVENT. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED.
Description of Event or Problem · 1
PATIENT WAS REVISED TO ADDRESS CHRONIC DISLOCATION (RIGHT SIDE).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PINN LNR CON +4 NEUT 32IDX54OD | 87KWZ | KWZ | DEPUY ORTHOPAEDICS, INC | NA | B46C91000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Required Intervention |