MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05 report with the FDA on 2002-09-27 for FLEX-FOOT RE-FLEX VSP RFX09300 FOOT ASSEMBLY * manufactured by Ossur North America, Inc..
[17831464]
Device assembly - lower limb external prosthetic leg assembly, comprising a hard socket with liner, which pt's residual limb rests in, attached to a prosthetic foot. The female pyramid attachment on the proximal end of prosthetic foot, that attaches to a mating male pyramid on the distal end of pt's hard-socket, became loose. As the pt stepped down on the prosthetic leg the foot portion twisted due to the loose pyramid, and the pt compensated for the sudden loss of balance by using their remaining sound limb to brace themselves. However, this resulted in pt losing their balance and falling, spraining their ankle on their sound limb. When initially reported to co in 2002 the injury event was not considered severe and no mdr was filed. This past 6/24/2002, the pt involved in this incident notified ossur directly to advise co that due to the sprained ankle on pt's sound limb pt had to have their sound limb amputated. The pt did not indicate to ossur that other health factors contributed to the need for an amputation. However, after several attempts, over a period of weeks, co finally were able to speak with the pt's prosthetists and he indicated that the pt was going to need their sound limb amputated for preexisting medical conditions. The prosthetists indicated that the sprained ankle only hastened the need for the amputation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2085446-2002-00001 |
| MDR Report Key | 419361 |
| Report Source | 04,05 |
| Date Received | 2002-09-27 |
| Date of Report | 2002-09-27 |
| Date of Event | 2002-03-16 |
| Date Facility Aware | 2002-03-16 |
| Report Date | 2002-03-25 |
| Date Reported to Mfgr | 2002-03-25 |
| Date Mfgr Received | 2002-03-25 |
| Device Manufacturer Date | 2001-06-01 |
| Date Added to Maude | 2002-10-02 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | WILLIAM HELD |
| Manufacturer Street | 27412 LAGUNA HILLS DRIVE |
| Manufacturer City | ALISO VIEJO CA 92656 |
| Manufacturer Country | US |
| Manufacturer Postal | 92656 |
| Manufacturer Phone | 9493603634 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLEX-FOOT RE-FLEX VSP |
| Generic Name | EXTERNAL, LOWER LIMB, PROSTHETIC FOOT, PYRAMID CONNECTOR |
| Product Code | ISH |
| Date Received | 2002-09-27 |
| Model Number | RFX09300 FOOT ASSEMBLY |
| Catalog Number | * |
| Lot Number | NA |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | 9 MO |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 408408 |
| Manufacturer | OSSUR NORTH AMERICA, INC. |
| Manufacturer Address | 27412 LAGUNA HILLS DRIVE ALISO VIEJO CA 92656 US |
| Baseline Brand Name | FLEX-FOOT RE-FLEX VSP |
| Baseline Generic Name | SHOCK ABSORBING CARBON-GRAPHITE PROSTHETIC FOOT |
| Baseline Model No | RFX09300 FOOT A |
| Baseline Catalog No | RFX00012 PYRAMID CONNECTOR |
| Baseline ID | NA |
| Baseline Device Family | FLEX-FOOT FEET PRODUCTS |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 2002 | 1. Deathisabilit | 2002-09-27 |