FDA Adverse Event
Injury
Summary report: N
ARTICUL/EZE BALL 28 +1.5 GR
MDR report key: 4122777
·
Received September 26, 2014
Report
- Report Number
- 1818910-2014-28910
- Event Type
- Injury
- Date Received
- September 26, 2014
- Date of Event
- September 17, 2014
- Report Date
- September 17, 2014
- Manufacturer
- JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD.3006356043
- Product Code
- JDI
- PMA / PMN Number
- PK883460
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE PRODUCT AND LOT CODE COMBINATIONS SINCE THEIR RELEASE TO DISTRIBUTION. THE INVESTIGATION CAN DRAW NO CONCLUSION WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED.
Additional Manufacturer Narrative · 1
THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).
Description of Event or Problem · 1
PATIENT WAS REVISED TO ADDRESS DISLOCATION AND LOOSENING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 600322 | ARTICUL/EZE BALL 28 +1.5 GR | HIP FEMORAL HEAD | JDI | JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD.3006356043 | D14061385 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 89 YR | Required Intervention |