MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-09-08 for PLIE' MPC KNEE KS1-00-KNEE-KT manufactured by Freedom Innovations, Inc. Corporate Office.
[1131178]
In 2009, the patient's prosthetist jack pranzarone notified our consulting prosthetist rep that the our plie' microprocessor-controlled knee (device) buckled when the patient fell in his home one month prior. To date we have received no objective evidence that the patient suffered injury as a result of the fall. During the following month, initial report, rep reported that the patient suffered damaged cervical tissue and loss of spine stability subsequent to the fall that will require surgery to correct, however, rep declined to assert that device malfunction caused the fall. During the same month, conversation with our national sales manager, the initial reporter, asserted that, during appointments subsequent to the fall, the patient had not attributed his fall to device malfunction.
Patient Sequence No: 1, Text Type: D, B5
[8407892]
Conclusion: device damaged sustained in the field while in use by the patient. Damage believed to be result of event rather than causal to event. In summary, the majority of the damage is consistent with a single fall, in which the patient fell on the knee cap hard enough to crack the rear surface of the battery box, and break the position sensor mounting. However, the knee shows evidence of multiple im-pacts. As a result, it is not possible to determine whether the position sensor breakage occurred before or during this incident. In general, it is possible that, after a position sensor mount has broken, a knee may continued to work intermittently or well for an indeterminate period of time. When the position sensor fails as seen in this inspection, the knee becomes stiff and less susceptible to falls. Oil loss caused by damage to the shaft could contribute to this event. Some loss of oil was apparent. It was not possible to determine the cause or timing of the damage to the shaft. The knee is repairable.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004737223-2009-00001 |
| MDR Report Key | 1464933 |
| Report Source | 05 |
| Date Received | 2009-09-08 |
| Date of Report | 2009-08-04 |
| Date of Event | 2009-07-13 |
| Date Mfgr Received | 2009-08-04 |
| Device Manufacturer Date | 2008-11-01 |
| Date Added to Maude | 2009-11-05 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | CRAIG WHITE, MANAGER |
| Manufacturer Street | 425 EAST 400 NORTH |
| Manufacturer City | GUNNISON UT 84634 |
| Manufacturer Country | US |
| Manufacturer Postal | 84634 |
| Manufacturer Phone | 8882395556 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PLIE' MPC KNEE |
| Product Code | ISS |
| Date Received | 2009-09-08 |
| Returned To Mfg | 2009-08-14 |
| Catalog Number | KS1-00-KNEE-KT |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FREEDOM INNOVATIONS, INC. CORPORATE OFFICE |
| Manufacturer Address | IRVINE CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-09-08 |