MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII CR DEEP FLEX ISRT S3-4 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71421536
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/28/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery of the pe insert was performed due to infection 16 months after primary surgery.After the device was explanted, it was noticed it appears to be yellowish.To treat the infection an implantation of cement spacer was performed.
Additional Manufacturer Narrative
The associated genesis ii cr deep flexion articular insert was returned and evaluated.A lab analysis conducted during this investigation indicated anterior deformation adjacent to the inserter divot features; posterior lock detail appears undamaged, and scratches and gouges on the inferior surface, and pale yellow color are observed on the inferior and superior surfaces.The exact causes of anterior deformations, scratches, pale yellow color, and slight wear on the superior condylar surfaces could not be determined from the investigation of the device.There were no observations of material or manufacturing deviations in the course of this investigation.The device was manufactured in 2017.Our investigation including a review of complaint history for 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.Product was sterilized according to sterilization release documentation from quality control.A clinical analysis noted that without the supporting pathology report, labs/laboratory findings and radiographic images the root cause of the reported infection nor the operative findings cannot be concluded.An infection occurring approximately 16 months post op is most likely hematogenously spread and not due to the implanted device.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: GII CR DEEP FLEX ISRT S3-4 9MM
• 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: 8017260
• Report Number: 1020279-2018-02281
• Device Sequence Number: 16583370
• Product Code: JWH
• UDI-Device Identifier: 03596010512444
• UDI-Public: 03596010512444
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K041825
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 04/03/2019

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: 71421536
• Device Lot Number: 17BM12178
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/01/2018
• Supplement Date Received by Manufacturer: 10/01/2018; 10/01/2018
• Initial Report FDA Received Date: 10/29/2018
• Supplement Report FDA Received Date: 02/11/2019; 04/03/2019
• 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: UNKNOWN FEMORAL DEVICE/ UNKNOWN LOT; UNKNOWN TIBIAL BASEPLATE/ UNKNOWN LOT
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention