FDA Adverse Event
Injury
Summary report: N
LCS COMPLETE FEM POR L STD+
MDR report key: 1214019
·
Received October 27, 2008
Report
- Report Number
- 1818910-2008-05058
- Event Type
- Injury
- Date Received
- October 27, 2008
- Date of Event
- October 14, 2008
- Report Date
- October 14, 2008
- Manufacturer
- DEPUY ORTHOPAEDICS, INC.
- Product Code
- MBH
- PMA / PMN Number
- P830055/R44
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVALUATION WAS NOT POSSIBLE, AS THE PRODUCTS WERE NOT RETURNED. PRODUCT INFORMATION REQUIRED TO REVIEW THE DEVICE HISTORY RECORDS WAS NOT PROVIDED. THE INVESTIGATION WAS LIMITED TO THE INFORMATION PROVIDED. THE INVESTIGATION COULD NOT VERIFY OR DRAW ANY CONCLUSIONS ABOUT REPORTED EVENT WITHOUT THE DEVICES TO EXAMINE AND FURTHER INFORMATION. BASED ON THE INVESTIGATION FINDINGS, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCTS AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.
Description of Event or Problem · 1
PATIENT REVISED TO ADDRESS LOOSE FEMORAL COMPONENT AND POLYETHYLENE WEAR OF BEARINGS; INTRAOPERATIVELY FOUND FRACTURED LATERAL CONDYLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LCS COMPLETE FEM POR L STD+ | 87MBH | MBH | DEPUY ORTHOPAEDICS, INC. | N/A | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Required Intervention |