MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-11-24 for NATURAL KNEE II CONSTRAINED KNEE SYSTEM 6720-19-101 manufactured by Zimmer Us Dba Center Pulse Orthopedic.
[2961969]
On (b)(6) 2012, while seated at my desk at work and moving from side to side in my rolling chair, my left tkr revision became "frozen" with my left leg in a bent position. I had severe pain and could not walk. Before the lot number: 1639631 was implanted, the doctor tried and removed the same catalog number piece as a lot number 1642665. Not sure if there was a defect or a fit problem.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5027914 |
| MDR Report Key | 2857733 |
| Date Received | 2012-11-24 |
| Date of Report | 2012-11-24 |
| Date of Event | 2012-09-04 |
| Date Added to Maude | 2012-12-06 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NATURAL KNEE II CONSTRAINED KNEE SYSTEM |
| Generic Name | TOTAL KNEE REPLACEMENT PLASTIC INSERT |
| Product Code | MBD |
| Date Received | 2012-11-24 |
| Model Number | NATURAL KNEE II |
| Catalog Number | 6720-19-101 |
| Lot Number | 1639631 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER US DBA CENTER PULSE ORTHOPEDIC |
| Manufacturer Address | PO BOX 708 1800 W CENTER ST WARSAW |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2012-11-24 |