MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII C/R ART INS SZ 5-6 18MM; PRSTHESS, KNE, PATELLOFMORTIBIAL, SEMICNSTRAINED, CEMNTED, PYMER/METAL/PLYMER

Catalog Number	71420508
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/23/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that malfunction has occurred during tkr revision procedure.Repeated attempts at insertion of genesis ii cr 18mm implant were unsuccessful (insert would not properly engage tibial tray with use of insertion tool).A second genesis ii cr insert was opened and implanted without further incident.There was a delay longer than 30 minutes reported.
Additional Manufacturer Narrative
The associated device was returned and evaluated.A dimensional inspection was attempted but the device was too damaged from the attempted insertion to obtain accurate measurements.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.The medical investigation concluded that, in the case reports, a malfunction occurred during tkr revision procedure.There were unsuccessful repeated attempts at insertion of genesis ii cr 18mm implant.The insert would not properly engage the tibial tray with use of insertion tool.A second genesis ii cr insert was opened and implanted without further incident.There was a delay longer than 30 minutes reported.Without the return of the of genesis ii implant, the root cause of the malfunction cannot be determined.Since no harm to the patient is being reported and a backup device was available, no further medical assessment is warranted.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: GII C/R ART INS SZ 5-6 18MM
• Common Device Name: PRSTHESS, KNE, PATELLOFMORTIBIAL, SEMICNSTRAINED, CEMNTED, PYMER/METAL/PLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8162301
• Report Number: 1020279-2018-02788
• Device Sequence Number: 2203531
• Product Code: JWH
• UDI-Device Identifier: 03596010207982
• UDI-Public: 03596010207982
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/28/2026
• Device Catalogue Number: 71420508
• Device Lot Number: 16DT68744
• Initial Date Received by Manufacturer: 11/26/2018
• Supplement Date Received by Manufacturer: 11/26/2018
• Initial Report FDA Received Date: 12/13/2018
• Supplement Report FDA Received Date: 10/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1