FDA Adverse Event
Injury
Summary report: N
P.F.C. 28MM HEAD +0MM
MDR report key: 899131
·
Received August 16, 2007
Report
- Report Number
- 1818910-2007-02738
- Event Type
- Injury
- Date Received
- August 16, 2007
- Date of Event
- August 6, 2007
- Report Date
- August 6, 2007
- Manufacturer
- DEPUY INTERNATIONAL, LTD.
- Product Code
- KWY
- PMA / PMN Number
- K893872
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, 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 PROD AND LOT CODES SINCE THEIR RELEASE FOR DISTRIBUTION. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PROD CONTRIBUTION TO THE REPORTED EVENT. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED.
Description of Event or Problem · 1
THE PT WAS REVISED BECAUSE OF PAIN AND DISLOCATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | P.F.C. 28MM HEAD +0MM | 87KWY | KWY | DEPUY INTERNATIONAL, LTD. | NA | XHN39 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Required Intervention |