MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN CR HIGH FLEX XLPE SZ 3-4 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71453112
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/14/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during tka procedure the lgn cr high flex xlpe sz 3 4 11mm was not delivered after it was used the day before.Was only noticed after the doctor decided to change the inlay for a secondary patella replacement in a legion knee in 2014.The doctor therefore had to re implant the removed inlay.The outcome of the patient is unknown.No apparent delay involved.No other complications were reported at this time.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A medical investigation was conducted and confirms this case reports that a patient underwent a revision of the poly insert.The reason for the revision remains unclear, as the requested information, surgical report and x-rays have not been provided.Without clinically relevant supporting clinical documentation, a thorough medical investigation cannot be performed, and the patient outcome beyond the revision cannot be confirmed.Therefore, no further clinical assessment is warranted at this time.Should clinically relevant documentation or information become available, the clinical/medical task may be re-evaluated.A review of complaint history did not revealed additional complaints for the listed device for the same failure mode.A review of risk management files and instructions for use found that the reported failure was documented appropriately.Factors and/or some potential probable causes that could contribute to the reported event have been identified as overuse or excessive pressure on the joint, injury, infection and/or patient condition.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: LGN CR HIGH FLEX XLPE SZ 3-4 11MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10804468
• Report Number: 1020279-2020-06267
• Device Sequence Number: 3773372
• Product Code: JWH
• UDI-Device Identifier: 00885556034323
• UDI-Public: 00885556034323
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2021

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: Health Professional
• Device Model Number: 71453112
• Device Catalogue Number: 71453112
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/14/2020
• Supplement Date Received by Manufacturer: 06/14/2021
• Initial Report FDA Received Date: 11/06/2020
• Supplement Report FDA Received Date: 06/17/2021
• 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