MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2001-11-01 for OSSUR ICELOCK CLUTCH 4H 214 L-214000 manufactured by Ossur Hf.
[238563]
Device assembly - lower limb external prosthetic leg. The pin attachment on the socket liner disengaged with the locking mechanism on the prosthetic limb. The foot section of the prosthesis subsequently became disconnected from the remainder of the prosthesis still on the pt's leg. The pt lost their balance and fell on their residual limb resulting in a fractured fibula. When this event was originally reported in 2001, it was indicated that the pt rec'd bruising and swelling but was otherwise ok. The co did pursue this event via the co's injury investigation procedure, and based on data gathered concluded it was not an mdr event. After several weeks the pt became dissatisfied with their recovery and sought a second opinion. The second opinion revealed the fracture. The medical advice was to stay off the residual limb and allow it to heal.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2085446-2001-00002 |
| MDR Report Key | 359804 |
| Report Source | 06,07 |
| Date Received | 2001-11-01 |
| Date of Report | 2001-06-21 |
| Date of Event | 2001-06-21 |
| Date Facility Aware | 2001-06-21 |
| Report Date | 2001-06-21 |
| Date Reported to Mfgr | 2001-06-21 |
| Date Mfgr Received | 2001-06-21 |
| Device Manufacturer Date | 1999-12-01 |
| Date Added to Maude | 2001-11-15 |
| 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 | RL |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OSSUR ICELOCK CLUTCH 4H 214 |
| Generic Name | PROSTHETIC LINER PIN LOCK MECHANISM |
| Product Code | ISH |
| Date Received | 2001-11-01 |
| Model Number | ICELOCK CLUTCH 4H 214 |
| Catalog Number | L-214000 |
| Lot Number | 996 |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | 1.5 YR |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 348985 |
| Manufacturer | OSSUR HF |
| Manufacturer Address | GRJOTHALS 5 REYKJAVIK IC IS-110 |
| Baseline Brand Name | OSSUR ICELOCK CLUTCH 4H 214 |
| Baseline Generic Name | PROSTHETIC LINER PIN LOCK MECHANISM |
| Baseline Model No | ICELOCK CLUTCH |
| Baseline Catalog No | L-214000 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2001-11-01 |