MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II CMT TIB SIZE 6 {} LEFT; PRSTHSIS,KNEE,PATLLFMROTIBL,SMI-CNSTRAIND,CEMENTED,POLYMER/METAL/POLYMER

Catalog Number	71420170
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/29/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed for a broken posterior tibia plateau.No delay, additional injuries or back up reported.
Additional Manufacturer Narrative
The associated genesis ii tibial baseplate and genesis ii articular insert were returned and evaluated.A lab analysis conducted during this investigation indicated that a portion of the posterior section of the tibial baseplate was fractured in the medial-lateral direction.The broken piece is returned.Scratches and remaining bone were observed on the posterior surface of the tibial baseplate.Burnishing, discoloration, and damage was observed on the articular surface of the tibial insert.Some localized deformation/damage was observed superiorly and inferiorly at the medial-posterior edge of the insert.The wear pattern on the insert is rotated.No material deviations were found during this investigation.Our investigation including a review of complaint history for the baseplate revealed no prior complaints for the listed failure mode with the same batch number.The device was manufactured in 2002.A review of the manufacturing records of the baseplate did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.A clinical evaluation noted that no relevant supporting documentation was provided, therefore a thorough medical investigation could not be performed.Our investigation could not determine a specific cause of the failure.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
Additional Manufacturer Narrative
Contains additional information.

• Brand Name: GNS II CMT TIB SIZE 6 {} LEFT
• Common Device Name: PRSTHSIS,KNEE,PATLLFMROTIBL,SMI-CNSTRAIND,CEMENTED,POLYMER/METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8083882
• Report Number: 1020279-2018-02535
• Device Sequence Number: 1619968
• Product Code: JWH
• UDI-Device Identifier: 03596010206282
• UDI-Public: 03596010206282
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/27/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: 71420170
• Device Lot Number: 02KT70790
• Initial Date Received by Manufacturer: 10/29/2018
• Supplement Date Received by Manufacturer: 10/29/2018; 10/29/2018
• Initial Report FDA Received Date: 11/19/2018
• Supplement Report FDA Received Date: 02/19/2019; 02/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PN 71420500 / BN 02JT70083 GII CRARTINS SZ5-6 9MM
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 70 YR