MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS HIGH FLEXION INSERT SZ 7-8 9MM; PRSTHESIS, KNE,PATELLOFEMOROTAINED, CEMENTED, POLYMER/METAL/POLYMER

Catalog Number	71421522
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/27/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a revision surgery for a possible tibial loosening, however, the surgeon discovered the post from the articular insert had broken.The broken part was lodged in the femoral notch.Surgeon chose to exchange the liner only.
Additional Manufacturer Narrative
The associated genesis ii ps high flexion insert was returned and evaluated.A lab analysis conducted during this investigation indicated that the device showed a fractured post.Damage was observed on the posterior edge of both condylar regions of the insert.Evidence of wear and deformation could be observed primarily on the posterior side of the post.Articulating surface of the insert showed fracture surface of the post, and evidences of wear, pitting and gouging damage.The causes of the post fracture on the tibial insert could not be determined from the investigation of the device.No evidence of material or manufacturing deviations were observed in this investigation.Our investigation including a review of complaint history for the listed product revealed no prior complaints for the listed failure mode with the same batch number.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.There is no information that would suggest the implanted device failed to meet specifications.A relationship, if any, between the device and the reported incident or adverse event could not be corroborated.The clinical evaluation team noted that there is no clinical relevant documentation provided, therefore a thorough medical investigation could not be performed.No additional actions are being taken at this time; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened and reevaluated.

• Brand Name: GII PS HIGH FLEXION INSERT SZ 7-8 9MM
• Common Device Name: PRSTHESIS, KNE,PATELLOFEMOROTAINED, CEMENTED, POLYMER/METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8184377
• Report Number: 1020279-2018-02850
• Device Sequence Number: 1279735
• Product Code: JWH
• UDI-Device Identifier: 03596010492975
• UDI-Public: 03596010492975
• Combination Product (Y/N): N
• PMA/510(K) Number: K032295
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2019

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: 71421522
• Device Lot Number: 07CT07822
• Initial Date Received by Manufacturer: 11/27/2018
• Supplement Date Received by Manufacturer: 11/27/2018
• Initial Report FDA Received Date: 12/20/2018
• Supplement Report FDA Received Date: 05/04/2019
• 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