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

Model Number	71453112
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330)
Date of Event	02/15/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, due to ongoing pain and discomfort it was decided to do a revision surgery.Implants were well fixed and there was no signs of infection.Soft tissue and bony debridement were completed.It was decided to perform a poly exchange.Patient outcome is unknown.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation, therefore the failure could not be confirmed.The clinical/medical team concluded, this case reports a revision surgery was performed due to ongoing pain and discomfort.It was further reported that there was no sign of infection, and the implants were well fixed.A soft tissue/bony debridement and poly exchange was performed.Per email correspondence, the requested surgical reports and x-rays are not available.Therefore, the patient impact beyond the revision and the clinical root cause of the pain and discomfort cannot be determined.Due to the limited information provided, no further clinical assessment can be rendered at this time.Should additional clinically relevant documentation become available, the clinical/medical task may be re-opened.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of risk management files and instructions for use found that the reported failure was documented appropriately.Possible causes could include but not limited to traumatic injury, patient anatomy or abnormal loading of limb.Should additional information be received, the complaint will be reopened.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.(b)(4).

• Brand Name: LGN CR HIGH FLEX XLPE SZ 3-4 11MM
• 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: 11478926
• Report Number: 1020279-2021-02085
• Device Sequence Number: 3625368
• Product Code: JWH
• UDI-Device Identifier: 00885556034323
• UDI-Public: 00885556034323
• 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 Implanted Year: 2018
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2021

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?: Yes
• Initial Date Received by Manufacturer: 02/15/2021
• Supplement Date Received by Manufacturer: 04/05/2021
• Initial Report FDA Received Date: 03/14/2021
• Supplement Report FDA Received Date: 04/16/2021
• 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