D
Patient 1
IT IS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN.
MAUDE MDR 2984921
- MDR report key
- 2984921
- Report number
- 1822565-2013-00405
- Event key
- 0
- Event type
- 3
- Date of event
- 2011-08-03
- Date received
- 2013-02-27
- 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
- KEVIN ESCAPULE
- 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 | NEXGEN CR-FLEX FEMORAL COMPONENT | ZIMMER, INC. | HSA | 00595201702 | 60406949 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2013-02-27 | 0 | 1. R |
Event Narratives#
N
Patient 1
EVALUATION SUMMARY: NO DEVICES, PHOTOS, PATIENT FACTOR INFORMATION, SURGICAL NOTES OR X-RAYS WERE RECEIVED. PAIN CAN BE INFLUENCED BY MANY FACTORS. THESE FACTORS INCLUDE, BUT ARE NOT LIMITED TO, PATIENT WEIGHT, PATIENT ACTIVITY, BONE QUALITY, IMPLANT SIZE, SURGICAL TECHNIQUE, AND REHABILITATION PROGRAM. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. EVALUATION: REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. 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 INVESTIGATION, 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.