MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. RENASYS GO; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 66801496

Device Problem Failure to Charge (1085)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/12/2019

Event Type  malfunction  

Event Description

It was reported that during treatment the battery was not charging.No delay or injury reported.A s&n back up device was available.

Manufacturer Narrative

As of today, device return has been requested for this complaint but has not yet been made available to the designated complaint unit for a full evaluation.Without return of the actual device we cannot further investigate or confirm the details supplied in this complaint and try to determine a root cause.If the device is returned in the future then this complaint may be reopened.

• 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 Key: 8326248
• MDR Text Key: 135738998
• Report Number: 8043484-2019-00106
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• PMA/PMN Number: K152163
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 03/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66801496
• Initial Date Manufacturer Received: 01/20/2019
• Initial Date FDA Received: 02/11/2019
• Supplement Dates Manufacturer Received: 03/21/2019
• Supplement Dates FDA Received: 03/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1