Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. RENASYS GO; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SMITH & NEPHEW MEDICAL LTD. RENASYS GO; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Catalog Number 66801496
Device Problem Failure to Charge (1085)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/07/2019
Event Type  malfunction  
Event Description
It was reported that unit does not charge.The patient with therapy at domicile went to the dressing change at the vascular surgery clinic where they decided to end the treatment since the conditions of the fermentation were still improved.
 
Manufacturer Narrative
The reported renasys device was received for evaluation at our testing facility.A visual inspection was performed on the exterior of product and damage was observed on the outer casing and device membrane.A functional evaluation was carried out and the reported issue could not be replicated; the device battery was found to be charging as expected with no issues.Following the complaint assessment, the necessary repairs were carried out and the device was again confirmed to be working as expected.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
RENASYS GO
Type of Device
PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
Manufacturer (Section D)
SMITH & NEPHEW MEDICAL LTD.
101 hessle road
hull
UK 
MDR Report Key8313624
MDR Text Key135367470
Report Number8043484-2019-00089
Device Sequence Number1
Product Code HRY
Combination Product (y/n)N
PMA/PMN Number
K152163
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup
Report Date 03/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/06/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number66801496
Device Lot NumberKHBM160127
Date Manufacturer Received01/17/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-