FDA Adverse Event
Injury
Summary report: N
12/14 ARTICUL 40MM M SPEC +12
MDR report key: 1241019
·
Received November 19, 2008
Report
- Report Number
- 1818910-2008-05257
- Event Type
- Injury
- Date Received
- November 19, 2008
- Date of Event
- October 31, 2008
- Report Date
- October 31, 2008
- Manufacturer
- DEPUY INTERNATIONAL, LTD.
- Product Code
- LPH
- PMA / PMN Number
- K060031
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, 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
THE PATIENT WAS REVISED BECAUSE OF INFECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 12/14 ARTICUL 40MM M SPEC +12 | 87LPH & 87 JDI | LPH | DEPUY INTERNATIONAL, LTD. | NA | 2326696 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Required Intervention |