NEXGEN CR-FLEX GSF FEMORAL COMPONENT
Report
- Report Number
- 1822565-2011-00829
- Event Type
- Injury
- Date Received
- March 31, 2011
- Report Date
- March 4, 2011
- Manufacturer
- ZIMMER, INC.
- Product Code
- MBH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ND, US
- Reporter Occupation
- PHYSICIAN
Narratives
EVAL SUMMARY: POST OPERATIVE X-RAYS FOR PRIMARY SURGERY WERE RETURNED FOR ANALYSIS. SURGEON OBSERVATION ON POST SURGICAL STATES X-RAYS TAKEN AT SIX WEEKS LOOK PERFECT, AND ONE YEAR FOLLOW-UP X-RAYS SHOW BONE RESORPTION AROUND THE END OF EACH IMPLANT. X-RAYS SHOW RADIOLUCENCIES ALONG THE PERIPHERY OF FEMUR BUT NOT CLEARLY VISIBLE ON THE TIBIAL COMPONENT. HOWEVER, OSTEOLYTIC LESIONS WERE OBSERVED NEAR THE POSTERIOR FEMORAL CONDYLES AND ON THE ANTERIOR FLANGE WHERE THE PATELLA TRACKS. RADIOLUCENCIES LEADING TO OSTEOLYSIS/COMPONENT LOOSENING, IN GENERAL, CAN BE DUE TO MANY FACTORS INCLUDING, BUT NOT LIMITED TO: INSUFFICIENT BONE CONTACT WITH THE IMPLANT, SURGICAL TECHNIQUE, MICRO-MOTION, PT ACTIVITY, OR PT WEIGHT. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND NAY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADD'L SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC CONSIDERS THE INVESTIGATION CLOSED.
IT IS REPORTED THAT THE PT IS PRESENTING WITH OSTEOLYSIS IN HER LEFT KNEE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEXGEN CR-FLEX GSF FEMORAL COMPONENT | MBH | ZIMMER, INC. | 61152541 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |