FDA Adverse Event
Injury
Summary report: N
UNKNOWN DEPUY CEMENT
MDR report key: 2082847
·
Received May 3, 2011
Report
- Report Number
- 1818910-2011-07557
- Event Type
- Injury
- Date Received
- May 3, 2011
- Date of Event
- April 4, 2011
- Report Date
- April 4, 2011
- Manufacturer
- DEPUY CMW
- Product Code
- LOD
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT ASSOCIATED WITH THIS REPORTED EVENT WAS NOT RETURNED EXAMINATION. THE PRODUCT CODE AND LOT CODE REQUIRED IN RETRIEVING THE DEVICE HISTORY RECORDS FOR REVIEWING AND SEARCHING THE COMPLAINT DATABASE WERE NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT BASED ON THE PROVIDED INFO. BASED ON THE PERFORMED INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSE AT THIS TIME. SHOULD THE PRODUCT AND/OR ADD'L INFO BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.
Description of Event or Problem · 1
PT REVISED FOR LOOSE TIBIAL TRAY AT CEMENT/IMPLANT INTERFACE AND FEMORAL COMPONENT IN EXTREME FLEXION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN DEPUY CEMENT | TOTAL KNEE REPLACEMENT | LOD | DEPUY CMW | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Required Intervention |