MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN PS HIGH FLEX XLPE SZ 5-6 13MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Model Number	71453223
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Discomfort (2330); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/15/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after patient complained of clucking when bending knee, surgeon revised and found a broken post on tibial insert therefore surgeon replaced with new 5-6 13mm insert.Patient outcome is unknown.
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 per complaint details, approximately 14 years post implantation the patient required revision due to ¿clunking when bending the knee¿ and ¿investigation confirmed¿ a broken tibial-insert post.It was communicated that the requested medical documentation was not available; however, the component may return for evaluation.Reportedly the root cause of the revision was the ¿clunking¿ and ¿broken¿ insert tibial loosening; however, without the requested medical documentation, the clinical root cause of the reported event could not be assessed.The patient impact beyond the reported symptomatic fractured post and subsequent revision could not be determined.No further medical assessment could be rendered at this time.Should clinically relevant documentation/information and/or product evaluation findings become available, the clinical/medical task may be re-evaluated.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of risk management files and instructions for use found that the reported failure was documented appropriately some potential probable causes for this event could include but not limited to traumatic injury, surgical technique, implant failure or design of device.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 PS HIGH FLEX XLPE SZ 5-6 13MM
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11644215
• Report Number: 1020279-2021-02814
• Device Sequence Number: 3157385
• Product Code: JWH
• UDI-Device Identifier: 00885556033425
• UDI-Public: 00885556033425
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K071071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2021

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 Expiration Date: 06/30/2018
• Device Model Number: 71453223
• Device Catalogue Number: 71453223
• Device Lot Number: 20BM14950
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/15/2021
• Supplement Date Received by Manufacturer: 05/19/2021
• Initial Report FDA Received Date: 04/09/2021
• Supplement Report FDA Received Date: 05/20/2021
• 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; Other; Required Intervention