MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION CON ART INS 9MM SZ 7-8; PROSTHESIS KNEE PATELLOFEMOROTIBIAL SEMICONSTRAINED CMNTD POLYMERMETALPOLYMER

Model Number	71420551
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/13/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to a luxation of the proximal tibia due to post traumatic events.
Additional Manufacturer Narrative
Results of investigation: it was reported that a revision surgery was performed due post traumatic event.Patient tilts over in squat and the knee prosthesis luxated.The affected legion constrained articular insert was returned and evaluated.A lab analysis conducted during this investigation noted that damage/deformation was observed on the articular surface of the insert; these features have been reported as being created by third-body particulate (bone cement, bone, etc.) in the joint space.Cement and bone particulate are known to be produced during a total knee arthroplasty (tka), even under carefully controlled conditions.The insert post is also damaged and scratched.Both the anterior and posterior surfaces of the post are deformed and damaged.No material or manufacturing deviations were observed.Our investigation including a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A relationship, if any, between the device and the reported incident or adverse event could not be corroborated.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.No further investigation 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.
Additional Manufacturer Narrative
Additional info: probable causes added to results of investigation per risk management file.Results of investigation: it was reported that a revision surgery was performed due to traumatic event.Patient tilts over in squat and the knee prosthesis luxated.The affected legion constrained articular insert, used in treatment, was returned and evaluated.A lab analysis conducted during this investigation noted that damage/deformation was observed on the articular surface of the insert; these features have been reported as being created by third-body particulate (bone cement, bone, etc.) in the joint space.Cement and bone particulate are known to be produced during a total knee arthroplasty (tka), even under carefully controlled conditions.The insert post is also damaged and scratched.Both the anterior and posterior surfaces of the post are deformed and damaged.No material or manufacturing deviations were observed.Our investigation including a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A relationship, if any, between the device 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.Per our risk management file, possible causes of dislocation could include but not limited to traumatic injury, patient anatomy or abnormal loading of limb.Based on this investigation, the need for corrective action is not indicated.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: LEGION CON ART INS 9MM SZ 7-8
• Common Device Name: PROSTHESIS KNEE PATELLOFEMOROTIBIAL SEMICONSTRAINED CMNTD POLYMERMETALPOLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8981132
• Report Number: 1020279-2019-03325
• Device Sequence Number: 3132471
• Product Code: JWH
• UDI-Device Identifier: 03596010555830
• UDI-Public: 03596010555830
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K962137
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/22/2020

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 Expiration Date: 08/07/2023
• Device Model Number: 71420551
• Device Catalogue Number: 71420551
• Device Lot Number: 13HM06786
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2019
• Initial Date Received by Manufacturer: 08/14/2019
• Supplement Date Received by Manufacturer: 08/14/2019; 08/14/2019
• Initial Report FDA Received Date: 09/10/2019
• Supplement Report FDA Received Date: 12/13/2019; 01/22/2020
• 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
• Patient Weight: 140