MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II CMT TIB SIZE 3 LEFT; PRSTHSS,KNEE,PTLLFMRTBIAL,SM-CNSTRAIND,CMNTD,POLYMER/MTL/POLYMER

Model Number	71420164
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Injury (2348)
Date of Event	07/23/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision of left tkr was performed due to patient presenting with pain with slight malalignment/malrotation of implant components.Primary left tkr was performed on (b)(6) 2017.During revision surgery the genesis ii non-porous tibial baseplate size 3 left was removed with renovation knee gear.Original oval 32mm patella was retained by surgeon.Bony canals and surfaces were prepped for a 5 left legion revision femur, 3 left revision tibia with tibial and femoral stems used with offset couplers and augmented femoral component.The components were trialled with rom check before implantation.The component implants used were cemented in with palacos cement and constrained 3-4 18mm insert implanted after cement curing.The wound was washed and irrigated, and betadine/saline soaked, and then closed in layers as per standard technique.
Additional Manufacturer Narrative
New information: g4,h1,h2,h3,h6,h7,h11.Results of investigation: it was reported that a revision of left tkr was performed due to patient presenting with pain with slight malalignment/malrotation of implant components.The affected genesis ii tibial baseplate, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.A review of the complaint history on the listed part revealed no prior complaints for the listed failure mode with the same batch number.A review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A relationship, if any, between the device and the reported incident could not be corroborated.A review of risk management files and the instructions for use found that the reported failure was documented appropriately.Possible causes could include but are not limited to surgical technique used, size of device or user/procedural variance.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: GNS II CMT TIB SIZE 3 LEFT
• Common Device Name: PRSTHSS,KNEE,PTLLFMRTBIAL,SM-CNSTRAIND,CMNTD,POLYMER/MTL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10418673
• Report Number: 1020279-2020-03996
• Device Sequence Number: 2990941
• Product Code: JWH
• UDI-Device Identifier: 03596010206251
• UDI-Public: 03596010206251
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2020

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 Model Number: 71420164
• Device Catalogue Number: 71420164
• Device Lot Number: 17HM21153
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/23/2020
• Supplement Date Received by Manufacturer: 10/23/2020
• Initial Report FDA Received Date: 08/18/2020
• Supplement Report FDA Received Date: 11/02/2020
• 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: Hospitalization; Required Intervention