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
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/10/2018
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7875133
• Report Number: 1020279-2018-01810
• Device Sequence Number: 16659374
• Product Code: HSX
• UDI-Device Identifier: 03596010501547
• UDI-Public: 03596010501547
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K912735
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2018

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: Health Professional
• Device Expiration Date: 01/04/2025
• Device Catalogue Number: 71243308
• Device Lot Number: 15AM03521
• Initial Date Received by Manufacturer: 08/20/2018
• Supplement Date Received by Manufacturer: 08/20/2018
• Initial Report FDA Received Date: 09/13/2018
• Supplement Report FDA Received Date: 11/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention