FDA Adverse Event
Injury
Summary report: N
UNK DEPUY CEMENT
MDR report key: 1444746
·
Received August 18, 2009
Report
- Report Number
- 1818910-2009-04528
- Event Type
- Injury
- Date Received
- August 18, 2009
- Date of Event
- July 27, 2009
- Report Date
- July 27, 2009
- Manufacturer
- DEPUY CMW
- Product Code
- LOD
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVALUATION WAS NOT POSSIBLE, AS THE PRODUCT WAS NOT RETURNED. PRODUCT INFO REQUIRED TO REVIEW THE DEVICE HISTORY RECORDS WAS NOT PROVIDED. THE INVESTIGATION COULD NOT VERIFY OR DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT BASED ON INSUFFICIENT INFO. BASED ON THE PERFORMED INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFO BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.
Description of Event or Problem · 1
THE PT WAS REVISED BECAUSE OF LOOSENING OF THE FEMORAL AND TIBIAL COMPONENTS, LITTLE TO NO CEMENT/IMPLANT BOND.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNK DEPUY CEMENT | BONE CEMENT | LOD | DEPUY CMW | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Required Intervention |