MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GEN II CEMENTED TIBIAL B/PLATE SZ 3 LEFT; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Model Number	71420164
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/16/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had her primary tka done on (b)(6) 2019 after which she damaged her collateral ligaments.Revision case was done with standard surgical technique and removal of implants in situ.Clinical and intra-operative findings showed severe damage to the medial and lateral collateral ligaments.This caused instability and primary knee needed to be revised to a hinge prosthesis.
Additional Manufacturer Narrative
It was reported that patient had a revision surgery due to severe damage to the medial and lateral collateral ligaments.The affected legion oxinium femoral component, legion ps high flexion insert and genesis ii cemented tibial baseplate, used in treatment, were returned and evaluated.A lab analysis conducted during this investigation noted that examination of the returned devices showed remnants of bone cement biological debris on the femoral and tibial baseplate.Scratches are observed on the femoral, insert and tibial baseplate; and dislocoration on the tibial insert.The scratching found on the devices could have likely been caused by the explantation of the parts.The discoloration is likely due to the absorption of biological fluids.A review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A review of complaint history on the listed parts revealed no prior complaints for the listed batch with the same failure mode.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A relationship between the devices and the reported incident could not be corroborated.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.Possible causes could include but not limited to traumatic injury or patient medical history.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: GEN II CEMENTED TIBIAL B/PLATE SZ 3 LEFT
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9150991
• Report Number: 1020279-2019-03544
• Device Sequence Number: 11436450
• Product Code: JWH
• UDI-Device Identifier: 03596010206251
• UDI-Public: 03596010206251
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2020

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: 18HT07756
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2019
• Initial Date Received by Manufacturer: 09/16/2019
• Supplement Date Received by Manufacturer: 02/19/2020
• Initial Report FDA Received Date: 10/03/2019
• Supplement Report FDA Received Date: 02/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1