D
Patient 1
IT IS REPORTED THAT THE DEVICE WAS IMPLANTED IN 2004 AND THAT THE PATIENT WAS REVISED IN 2005 DUE TO A SNAPPING-PHENOMENON, SUBLUXATION, DISLOCATION AND PAIN.
MAUDE MDR 1561185
- MDR report key
- 1561185
- Report number
- 1822565-2009-01202
- Event key
- 0
- Event type
- 3
- Date of event
- 2005-02-10
- Date received
- 2009-12-16
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- BRIAN FIEDLER
- Address
- P.O. BOX 708 WARSAW IN 46581 US
- Phone
- 800-800-8006
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN NEXGEN ROTATING HINGE KNEE ARTICULAR SURFACE WITH HINGE POST EXTESION PI | KNEE PROSTHESIS | ZIMMER, INC. | HRZ | NA | UNK | UNK | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2009-12-16 | 0 | 1. H; 2. R |
Event Narratives#
N
Patient 1
EVALUATION SUMMARY: NO PRODUCT WAS RETURNED FOR EVAL. ALSO, NO X-RAYS WERE RETURNED FOR REVIEW. PT INFO SUCH AS HEIGHT, WEIGHT, AND PT ACTIVITY IS UNK. BASED ON THE AVAILABLE INFO, A DEFINITIVE ROOT CAUSE CANNOT BE ASCERTAINED AT THIS TIME. NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS WAS ALSO NOT POSSIBLE AS THE PRODUCT AND/OR LOT NUMBERS REQUIRED FOR RETRIEVAL WERE UNAVAILABLE. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE AVAILABLE INFORMATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.