MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII QUICK CONNECT HANDLE; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number OR71440044

Device Problem Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/01/2019

Event Type  malfunction  

Event Description

It was reported that during 2 tkas, dr.Reported that the quick connect handles were not staying locked onto the tibia baseplates.He was able to trial without and the cases were completed without patient harm or surgical delay.No closure letter required and products will be shipped back once replacements are received.

Manufacturer Narrative

This complaint has been re-evaluated for mdr reporting.Therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

• Brand Name: GII QUICK CONNECT HANDLE
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: sarah freestone ; 1450 brooks road; memphis, TN 38116 ; 0447940038
• MDR Report Key: 9250702
• MDR Text Key: 164271592
• Report Number: 1020279-2019-03769
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 03596010213860
• UDI-Public: 03596010213860
• Combination Product (y/n): N
• PMA/PMN Number: K121393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/22/2019

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: Health Professional
• Device Catalogue Number: OR71440044
• Device Lot Number: UNKNOWN/UNREADABLE
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/01/2019
• Initial Date FDA Received: 10/29/2019
• Supplement Dates Manufacturer Received: 10/01/2019
• Supplement Dates FDA Received: 11/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1