MAUDE Adverse Event Report: 3003764610 RHEO KNEE

Model Number	RKN130003
Health Effect - Clinical Codes	Fall (1848); Hip Fracture (2349)
Date of Event	02/27/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: RHEO KNEE
• Manufacturer (Section D): 3003764610; grjothals 5; reykjavik, reykjavik 110 ; IC 110
• MDR Report Key: 7634307
• Report Number: 2085446-2018-00002
• Device Sequence Number: 2482262
• Product Code: ISW
• UDI-Device Identifier: 05690967595418
• UDI-Public: 05690967595418
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Was the Report Sent to FDA?: No
• Device Age: 4 MO
• Event Location: Other
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/24/2018
• Initial Report FDA Received Date: 06/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HIP SURGERY DUE TO BREAK DURING FALL
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 47 YR
• Patient Weight: 111