MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GEN TIB PLY OLAY M LM/RL 8MM; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 71243308

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 07/10/2018

Event Type  Injury  

Event Description

It was reported that during surgery, the implant has been checked at its removal from the packaging.It was a medium implant of 8 mm.It has been cemented on the patient but was not adapted to the patient.Explantation of the implant because its size was not medium compared to the trial implant but large.Use of a backup implant.

Manufacturer Narrative

The associated complaint device was returned and evaluated.A visual inspection of the returned genesis uni tibia poly onlay indicated the presence of cement in the grooves.There was surface damage on the distal side, indicating attempted use.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A dimensional evaluation indicated that onlay indicated that it was correctly sized.A review of complaint history on the listed parts revealed no prior complaints for the listed batches.A clinical analysis indicated that based on the available information and the dimensional evaluation of the returned product, a root cause of the insert ¿not adapting to the patient¿ cannot be concluded as the dimensional analysis found the product to be correct with the labeling.No clinical/medical records or x-rays were provided for this investigation.No information on the patient¿s current status has been provided.Based on this investigation, the need for corrective action is not indicated.However, we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: GEN TIB PLY OLAY M LM/RL 8MM
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7875133
• MDR Text Key: 120235413
• Report Number: 1020279-2018-01810
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 03596010501547
• UDI-Public: 03596010501547
• Combination Product (y/n): N
• PMA/PMN Number: K912735
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71243308
• Device Lot Number: 15AM03521
• Date Manufacturer Received: 08/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention