MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GEN II COCR PS NP FEMORAL COMPSZ 3 RIGHT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71420116
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/17/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to gonarthrosis and instability in knee.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A clinical analysis indicates that it was reported on (b)(6) 2016, the patient underwent a total knee cemented prosthesis implant for gonarthrosis.The patient complained of gonalgia and feeling of failure / instability of the operated knee.Two years later, the patient underwent prosthesis removal and re-implantation with total knee restorative prosthesis.No clinically relevant information was provided for inclusion in this investigation.Without the request clinical information the root cause of the gonalgia and feeling of failure / instability of the operated knee cannot be concluded.The future impact to the patient cannot be concluded due to the lack of clinical information.No further clinical/medical assessment is warranted at this time.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 complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.
Additional Manufacturer Narrative
The associated genesis ii ps femoral component was not returned for evaluation.The device was manufactured in 2016.Our investigation including 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 complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.A clinical evaluation indicated that without the requested clinical information the root cause of the gonalgia and feeling of failure/or instability of the operative knee cannot be concluded.The patient¿s age, bone quality, and/or body habitus as contributing factors cannot be ruled out.The future impact to the patient cannot be concluded due to the lack of clinical information.No further clinical/medical assessment is warranted at this time.Without the return of the actual product involved, our investigation of this report is inconclusive.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.Should additional information be received, the complaint will be reopened.

• Brand Name: GEN II COCR PS NP FEMORAL COMPSZ 3 RIGHT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7251884
• Report Number: 1020279-2018-00134
• Device Sequence Number: 13771638
• Product Code: JWH
• UDI-Device Identifier: 03596010206022
• UDI-Public: 03596010206022
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 11/20/2018

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: 01/25/2026
• Device Catalogue Number: 71420116
• Device Lot Number: 16AM18035
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/29/2018
• Supplement Date Received by Manufacturer: 01/29/2018; 01/29/2018
• Initial Report FDA Received Date: 02/08/2018
• Supplement Report FDA Received Date: 04/12/2018; 11/20/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 75 YR