FDA Adverse Event
Injury
Summary report: N
ARTICUL/EZE BALL 28 +8.5 BL
MDR report key: 1241023
·
Received November 19, 2008
Report
- Report Number
- 1818910-2008-05277
- Event Type
- Injury
- Date Received
- November 19, 2008
- Date of Event
- October 31, 2008
- Report Date
- October 31, 2008
- Manufacturer
- DEPUY INTRNATIONAL, LTD.
- Product Code
- JDI
- PMA / PMN Number
- K883460
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EXAMINATION WAS NOT POSSIBLE, AS THE DEVICES WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT CODES SINCE THEIR 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 DISLOCATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ARTICUL/EZE BALL 28 +8.5 BL | 87JDI | JDI | DEPUY INTRNATIONAL, LTD. | NA | XVP47 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 DA | Required Intervention |