FDA Adverse Event
Injury
Summary report: N
MBT CEM KEEL TIB TRAY SZ3
MDR report key: 2060677
·
Received April 6, 2011
Report
- Report Number
- 1818910-2011-05759
- Event Type
- Injury
- Date Received
- April 6, 2011
- Date of Event
- March 8, 2011
- Report Date
- March 8, 2011
- Manufacturer
- DEPUY (IRELAND)
- Product Code
- NJL
- PMA / PMN Number
- P830055/S095
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT ASSOCIATED WITH THIS REPORTED EVENT WAS NOT RETURNED FOR EXAMINATION. A SEARCH OF THE COMPLAINT DATABASE DID NOT SHOW ANY ADDITIONAL REPORTS AGAINST THE PRODUCT LOT CODE. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE ROOT CAUSE OF THE REPORTED TIBIAL TRAY LOOSENING. PROVIDED INFORMATION STATED THE PATIENT EXPERIENCED TRAUMA (FELL) IN 2009, AND THE TIBIAL TRAY RECESSED. NO EVIDENCE WAS FOUND SUGGESTING PRODUCT ERROR WAS A CONTRIBUTING FACTOR AND THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.
Description of Event or Problem · 1
PATIENT REVISED FOR LOOSE TIBIAL TRAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MBT CEM KEEL TIB TRAY SZ3 | 87 NJL | NJL | DEPUY (IRELAND) | NA | 2420566 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Required Intervention |