FDA Adverse Event
Injury
Summary report: N
ARICUL/EZE BALL 32+1 GR
MDR report key: 1040098
·
Received May 7, 2008
Report
- Report Number
- 1818910-2008-01680
- Event Type
- Injury
- Date Received
- May 7, 2008
- Date of Event
- April 22, 2008
- Report Date
- April 22, 2008
- Manufacturer
- DEPUY INTERNATIONAL, LTD.
- Product Code
- JDI
- PMA / PMN Number
- K883460
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, 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 RELATED 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. DEPUY CONSIDERS THIS INVESTIGATION CLOSED. SHOULD THE PRODUCT OR ADD'L INFO THAT CHANGES THIS CONCLUSION BE RECEIVED, THE INVESTIGATION WILL BE REOPENED.
Description of Event or Problem · 1
PT REVISED TO ADDRESS DISLOCATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ARICUL/EZE BALL 32+1 GR | 87JDI | JDI | DEPUY INTERNATIONAL, LTD. | NA | 2317293 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Required Intervention |