FDA Adverse Event
Malfunction
Summary report: N
CONSENSUS KNEE SYSTEM
MDR report key: 4232333
·
Received July 30, 2014
Report
- Report Number
- 2952369-2014-00002
- Event Type
- Malfunction
- Date Received
- July 30, 2014
- Date of Event
- February 27, 2014
- Report Date
- July 28, 2014
- Manufacturer
- CONSENSUS ORTHOPEDICS INC.
- Product Code
- JWH
- PMA / PMN Number
- K102927
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ID, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
CONFIRMED PATIENT - SURGEON INVOLVEMENT, PULLED LOT RECORDS AND EVALUATED DHR'S FOR ANY ANOMALIES WHILE ALSO EVALUATING COMPLAINT FILES FOR SIMILAR ISSUES. LACK OF EVIDENCE TO FURTHER EVALUATE MANUFACTURING OR DESIGN DEFECT OR SURGEON ERROR IN SIZE SELECTION OF ORIGINAL IMPLANT. PART/CATALOG #: 2153-0-0002 (L), RLP/NP FEMORAL SZ 2, COCR/TI, LOT #: 171226; 2581-0-0001 (L), RLP/NP STEMMED TIB BASE SZ 1, COCR 475843; 2764-0-7501, PATELLA, ROUND UHMWPE SZ 1, 7.5MM, 475292.
Description of Event or Problem · 1
AT 18 MONTHS POST-OP THE PATIENT DECIDED TO HAVE THE COI IMPLANT REPLACED BECAUSE IT WAS SUPPOSEDLY "OVER-SIZED" AND WAS NOT COMFORTABLE. THE REVISION TO AN UNKNOWN SYSTEM WAS COMPLETED BY A DIFFERENT SURGEON (J. SMITH) THAN THE ONE WHO DID THE ORIGINAL COI KNEE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 444301 | CONSENSUS KNEE SYSTEM | TOTAL KNEE SYSTEM | JWH | CONSENSUS ORTHOPEDICS INC. | 2141-1-1210 | 476222 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Required Intervention |