MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN CR HIGH FLEX XLPE SZ 3-4 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED,

Model Number	71453111
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that a revision surgery of legion primary cr prosthesis was performed due to malrotation femur.The legion cr high flex xlpe sz 3-4 9mm was revised and exchanged.The patient was discharged from hospital.
Additional Manufacturer Narrative
It was reported that a revision surgery of legion primary cr prosthesis was performed due to malrotation femur.The genesis ii cmt tibial size 4 left, legion narrow cr oxin sz 5n lt and legion cr high flex xlpe sz 3-4 9mm were revised and exchanged.The patient was discharged from hospital.The affected complaint device, used in treatment, was returned and evaluated.A visual inspection of the returned device shows damage on the lock detail and scratches on the surface of the part.A review of the complaint history on 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.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.A review of risk management files and the instructions for use found that the reported failure was documented appropriately.A clinical evaluation noted that the primary implantation operative report was provided and translated.However, the requested revision operative reports and x-rays have not been provided.Without clinically relevant supporting documentation, a thorough medical investigation cannot be performed.Therefore, the patient impact beyond the revision cannot be determined.Due to the limited information provided, no further clinical assessment is warranted.The cause of the revision was stated as due to malrotation of the femur.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.We consider this investigation closed.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical evaluation concluded that this complaint reports a revision due to malrotation of the femur.The primary implantation operative report was provided and translated.However, the requested revision operative reports and x-rays have not been provided.Without clinically relevant supporting documentation, a thorough medical investigation cannot be performed.Therefore, the patient impact beyond the revision cannot be determined.Due to the limited information provided, no further clinical assessment is warranted.Should additional clinically relevant documentation become available, the clinical/medical task may be re-opened.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documents revealed this failure mode and potential harm was previously identified.Possible causes 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.Without the return of the actual product involved or product information, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.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.D9, h3, h6, h10.

• Brand Name: LGN CR HIGH FLEX XLPE SZ 3-4 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED,
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11001985
• Report Number: 1020279-2020-07400
• Device Sequence Number: 10935327
• Product Code: JWH
• UDI-Device Identifier: 00885556033975
• UDI-Public: 00885556033975
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K071071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• 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): 10/05/2021

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: Lay User/Patient
• Device Model Number: 71453111
• Device Catalogue Number: 71453111
• Device Lot Number: 17LM05304
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 02/12/2021
• Initial Date Received by Manufacturer: 11/17/2020
• Supplement Date Received by Manufacturer: 05/18/2021; 10/05/2021
• Initial Report FDA Received Date: 12/14/2020
• Supplement Report FDA Received Date: 05/27/2021; 10/05/2021
• 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