FDA Adverse Event
Injury
Summary report: N
PINNACLE MTL INS NEUT36IDX58OD
MDR report key: 1253052
·
Received December 4, 2008
Report
- Report Number
- 1818910-2008-05826
- Event Type
- Injury
- Date Received
- December 4, 2008
- Date of Event
- November 20, 2008
- Report Date
- November 20, 2008
- Manufacturer
- DEPUY INTERNATIONAL, LTD.
- Product Code
- KWA
- PMA / PMN Number
- K073504
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, 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 KNOWN 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
THE PATIENT WAS REVISED BECAUSE OF DISLOCATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PINNACLE MTL INS NEUT36IDX58OD | 87KWA; 87LZO | KWA | DEPUY INTERNATIONAL, LTD. | NA | 2637852 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Required Intervention |