FDA Adverse Event
Malfunction
Summary report: N
MONOGRAM CERAMIC CUTTING BLOCK #2, MD/LG
MDR report key: 106175
·
Received July 14, 1997
Report
- Report Number
- 2219689-1997-00375
- Event Type
- Malfunction
- Date Received
- July 14, 1997
- Date of Event
- February 10, 1997
- Report Date
- July 11, 1997
- Manufacturer
- HOWMEDICA INC.
- Product Code
- MDM
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
SUMMARY OF EVALUATION: EXAMINATION RESULTS SUGESTS THAT THIS EVENT IS NOT DEVICE RELATED.
Description of Event or Problem · 1
REPORTER SATES, "THE FEMUR WAS CUT USING THE CERAMIC CUTTING BLOCKS. WHEN THE FEMORAL COMPONENT WAS PUT ON IT APPEARED TO FIT. WHEN THE KNEE WAS PUT OUT TO EXTENSION, IT FELT LOOSE ON ALL CUTS. IT WAS LOOSE BY APPROXIMATELY 1" ON BOTH SIDES. ATTEMPTED TO IMPLANT WITH THE KNEE POSITIONED DOWN IN FLEXION, HOWEVER WHEN THE KNEE WAS PLACED IN EXTENSION, THE SAME RESULTS WERE NOTED. THE SURGEON USED BONE CEMENT TO COMPLETE THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MONOGRAM CERAMIC CUTTING BLOCK #2, MD/LG | INSTRUMENT | MDM | HOWMEDICA INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Other | CATALOG#6632-0-410/LOT#CRXLA DURACON MODULAR| FEMORAL COMPONENT. STABLECUT BLADE |