MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,06 report with the FDA on 2001-07-26 for OSSUR ICEROSS LINER ICEROSS, TWO COLOR LINER I-010232 manufactured by Ossur Hf.
[216672]
Device assembly - lower limb prosthetic leg for above knee amputee. Assembly consists of ossur iceross liner/(non-ossur product), custom made hard socket/(non-ossur product), custom made lanyard/united states manufacturing company knee frame/mauch knee cylinder/flex-foot brand foot. The (non-ossur product) custom made lanyard bolt connecting the iceross liner to the hard socket came loose, disengaged, and patient's prosthetic leg assembly, sans iceross liner, came off patient's leg. Patient essentially walked right out of prosthesis. Patient fell to ground, reportedly landing on residual limb/stump resulting in compound fracture of femur. Hospitalization and surgery required to ensure patient's healthy recovery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2085446-2001-00001 |
| MDR Report Key | 343918 |
| Report Source | 04,06 |
| Date Received | 2001-07-26 |
| Date of Report | 2001-07-25 |
| Date of Event | 2001-05-10 |
| Date Facility Aware | 2001-05-10 |
| Report Date | 2001-07-25 |
| Date Reported to Mfgr | 2001-06-27 |
| Date Mfgr Received | 2001-06-27 |
| Device Manufacturer Date | 1999-09-01 |
| Date Added to Maude | 2001-07-30 |
| 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 HILL DR |
| 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 | RL |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OSSUR ICEROSS LINER |
| Generic Name | FORM FITTING SILICONE INTERFACE/COVER FOR LOWER LIMB AMPUTE |
| Product Code | ISH |
| Date Received | 2001-07-26 |
| Returned To Mfg | 2001-07-23 |
| Model Number | ICEROSS, TWO COLOR LINER |
| Catalog Number | I-010232 |
| Lot Number | 91499 |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | 22 MO |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 333254 |
| Manufacturer | OSSUR HF |
| Manufacturer Address | GRJOTHALS 5 REYKJAVIK IC IS-110 |
| Baseline Brand Name | OSSUR ICEROSS LINER |
| Baseline Generic Name | FORM FITTING SILICONE INTERFACE/COVER FOR LOWER LIMB AMPUTE |
| Baseline Model No | ICEROSS, TWO CO |
| Baseline Catalog No | I-010232 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2001-07-26 |