MAUDE Adverse Event Report: 3003764610 RHEO KNEE

Model Number RKN130003

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Fall (1848); Hip Fracture (2349)

Event Date 02/27/2018

Event Type  Injury  

Manufacturer Narrative

The patient has only been using knee for a short period of time and it is known that tf amputees are known to fall more frequently, regardless of product malfunction but with low occurrence of injuries.We received the loaner knee back after incident, we conducted our tests and verification activities, and based on those we haven't found any abnormalities / issues.However, because of the customer reporting that he was injured in this instance, we conducted further analysis to confirm that there is nothing wrong with the knee.That additional analysis have provided no reason to suspect such an issue.This is considered an isolated event in severity of injury.

Event Description

A week or two weeks into original knee, started experiencing issues, knee was shuddering (no other issues besides shuddering).Sent primary knee in for servicing and received a loaner knee.While on a loaner knee he fell ((b)(6) 2018) and broke his hip, the next day (b)(6) 2018 received surgery.He was on loaner knee from (b)(6) 2017 until (b)(6) 2018.After fall he went to the hospital; diagnosed with fractured hip; received mri, cat scan and xrays, than emergency surgery next morning.Currently no medication is being utilized, has been attending therapy twice a week and has already completed for a whole month.

• Brand Name: RHEO KNEE
• Type of Device: RHEO KNEE
• Manufacturer (Section D): 3003764610; grjothals 5; reykjavik, reykjavik 110 ; IC 110
• Manufacturer (Section G): OSSUR AMERICAS, INC.; 27051 towne centre; foothill CA 92610
• Manufacturer Contact: ubaldo anaya ; 27051 towne centre; foothill ranch, CA 92610 ; 9493033239
• MDR Report Key: 7634307
• MDR Text Key: 112197789
• Report Number: 2085446-2018-00002
• Device Sequence Number: 1
• Product Code: ISW
• UDI-Device Identifier: 05690967595418
• UDI-Public: 05690967595418
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/07/2018

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: RKN130003
• Device Catalogue Number: RKN130003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Device Age: 4 MO
• Event Location: Other
• Initial Date Manufacturer Received: 05/24/2018
• Initial Date FDA Received: 06/25/2018
• 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: Initial
• Patient Sequence Number: 1
• Treatment: HIP SURGERY DUE TO BREAK DURING FALL
• Patient Outcome(s): Hospitalization
• Patient Age: 47 YR
• Patient Weight: 111