MAUDE Adverse Event Report: OSSUR ICELAND RHEO KNEE; ASSEMBLY, KNEE/SHANK/ANKLE/FOOT, EXTERNAL

Model Number RKN120007

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Laceration(s) (1946)

Event Date 12/25/2015

Event Type  No Answer Provided  

Manufacturer Narrative

Health professional does not believe the rheo knee failed or contributed to the event.We are anticipating the receipt of the product for analysis.Upon completion with analysis we will submit a supplemental report.

Event Description

Above knee amputee patient fell and hit her head.She went to the emergency room and is expected to make a full recovery.She obtained a cut on her upper eyelid and received a dermabond stitch.Patient's prosthetist does not feel the rheo knee failed or caused the fall.

Manufacturer Narrative

No product malfunction was identified that could have contributed to the incident.

Event Description

Above knee amputee patient fell and hit her head.She went to the emergency room and is expected to make a full recovery.She obtained a cut on her upper eyelid and received a dermabond stitch.Patient's prosthetist does not feel the rheo knee failed or caused the fall.

• Brand Name: RHEO KNEE
• Type of Device: ASSEMBLY, KNEE/SHANK/ANKLE/FOOT, EXTERNAL
• Manufacturer (Section D): OSSUR ICELAND; grjothals 5; reykjavik, 110 ; IC 110
• Manufacturer (Section G): OSSUR ICELAND; grjothals 5; reykjavik, 110 ; IC 110
• Manufacturer Contact: karen montes ; 27051 towne centre drive; foothill ranch, CA 92610 ; 9493823741
• MDR Report Key: 5392210
• MDR Text Key: 36892709
• Report Number: 3003764610-2016-00002
• Device Sequence Number: 1
• Product Code: ISW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: RKN120007
• Device Catalogue Number: RKN120007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/05/2016
• Initial Date FDA Received: 01/26/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR