MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GENESIS II DISHED ARTICULAR INSERT SIZE 3-4 11MM; PRSTHSS,KNEE,PTLLFMRTBIAL,SM-CNSTRAIND,CMNTD,POLYMER/MTL/POLYMER

Model Number	71420768
Medical Device Problem Codes	Degraded (1153); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Injury (2348)
Date of Event	08/18/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, 16 years after a tka surgery had been performed, the patient experienced pain in the knee posterior section.On revision surgery, it was noticed that there was minimal wear on the insert, mostly posterior, which caused pain, so the surgeon decided to exchange it since everything else was very well in place and stable.The patient outcome is unknown.
Additional Manufacturer Narrative
G3, h2,h3 and h6: the device, used in treatment, was not returned for evaluation.The pictures provided were reviewed and could not confirm the stated failure mode.The clinical / medical investigation concluded that, this complaint from south africa reports wear on the poly implant after 16 years.Reportedly, ¿it was noticed that there was minimal wear on the insert, mostly posterior, which caused pain, so the surgeon decided to exchange it since everything else was very well in place and stable.¿ the patient outcome is unknown.X-rays were provided for review which demonstrate a posterior positioned tibial base plate as well as a femoral component that has some radiolucency anteriorly but the revision confirmed that components were well fixed.No further information has been provided.Smith and nephew has not received adequate materials (operative reports) to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.The impact to the patient beyond the surgery and recovery cannot be determined with the available information.In conclusion, based on the limited information the root cause of the wear cannot be definitively concluded, however 16 years insitu one would expect some wear.This may be normal wear and not a failure of the insert but cannot be concluded without the product for evaluation.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.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Wear potential causes could include but are not limited to friction, joint tightness or lifetime of device.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or 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.We consider this investigation closed.D10: concomitants updated.E1: initial reporter name update.

• Brand Name: GENESIS II DISHED ARTICULAR INSERT SIZE 3-4 11MM
• 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: 10540892
• Report Number: 1020279-2020-04614
• Device Sequence Number: 3124322
• Product Code: JWH
• UDI-Device Identifier: 03596010209337
• UDI-Public: 03596010209337
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 07/22/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/02/2014
• Device Model Number: 71420768
• Device Catalogue Number: 71420768
• Device Lot Number: 04GM10852
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/18/2020
• Supplement Date Received by Manufacturer: 07/20/2021
• Initial Report FDA Received Date: 09/16/2020
• Supplement Report FDA Received Date: 07/22/2021
• 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: GII OXINIUM FEM SIZE 6 LEFT/05CM01650; GNS II CMT TIB SIZE 4 LEFT/04MM08329
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention