FDA Adverse Event
Injury
Summary report: N
S-ROM HEAD FEMORAL COCR 32+3
MDR report key: 1222499
·
Received November 5, 2008
Report
- Report Number
- 1818910-2008-05179
- Event Type
- Injury
- Date Received
- November 5, 2008
- Date of Event
- October 23, 2008
- Report Date
- October 23, 2008
- Manufacturer
- DEPUY INTERNATIONAL, LTD.
- Product Code
- JDG
- PMA / PMN Number
- K920317
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, 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
PATIENT WAS REVISED TO ADDRESS DISLOCATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | S-ROM HEAD FEMORAL COCR 32+3 | 87JDG | JDG | DEPUY INTERNATIONAL, LTD. | NA | 2518529 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Required Intervention |