MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN HK FEM ASSEMBLY SZ 5 RT; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	71421365
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Infiltration into Tissue (1931); Injury (2348)
Date of Event	01/01/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the clinical subject experienced neuropathic pain following the procedure.This condition has consequences for normal daily living and social life.The event was treated via infiltration and its not considered resolved.
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 it was reported that following the (b)(6) 2019 hk implantation, the clinical subject experienced an onset of neuropathic pain on an unspecified date in 2020, which required unidentified treatment via medication therapy/infiltration.The event was reviewed and classified as a sade with pain in the region of pes anserinus with consequences for normal daily living and social life.The 03/08/2021 attachment/team notification communicated that the ¿status changed to resolved on (b)(6) 2020¿.Per the one-stage operative information crf, joint line and patella height corrections were required during the implantation/study hk procedure.However, based on the information provided, the clinical root cause of the reported events could not be definitively concluded.The patient impact beyond the reported pain event and subsequent interventions could not be determined.No further medical assessment could be rendered at this time.Should clinically relevant documentation/information become available, the clinical/medical task may be re-evaluated.A review of complaint history for the listed part revealed no prior complaints for the listed batch.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, joint tightness, material in use, patient reaction or loss of sterility.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.
Additional Manufacturer Narrative
H3, h6: 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 it was reported that following the (b)(6) 2019 hk implantation, the clinical subject experienced an onset of neuropathic pain on an unspecified date in 2020, which required unidentified treatment via medication therapy/infiltration.The event was reviewed and classified as a sade with pain in the region of pes anserinus with consequences for normal daily living and social life.The (b)(6) 2021 attachment/team notification communicated that the ¿status changed to resolved on (b)(6) 2020¿.Per the one-stage operative information crf, joint line and patella height corrections were required during the implantation/study hk procedure.However, based on the information provided, the clinical root cause of the reported events could not be definitively concluded.The patient impact beyond the reported pain event and subsequent interventions could not be determined.No further medical assessment could be rendered at this time.Should clinically relevant documentation/information become available, the clinical/medical task may be re-evaluated.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, joint tightness, material in use, patient reaction or loss of sterility.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.

• Brand Name: LGN HK FEM ASSEMBLY SZ 5 RT
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10536418
• Report Number: 1020279-2020-04578
• Device Sequence Number: 4060476
• Product Code: KRO
• UDI-Device Identifier: 00885556414934
• UDI-Public: 00885556414934
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/22/2021

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: 71421365
• Device Catalogue Number: 71421365
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/17/2020
• Supplement Date Received by Manufacturer: 06/24/2021; 09/22/2021
• Initial Report FDA Received Date: 09/15/2020
• Supplement Report FDA Received Date: 06/25/2021; 09/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 71421029; 71421386; 71421905; 71422159; 71422159; 71423355; 71424049; 71424051; 71424225
• Outcome Attributed to Adverse Event: Other; Required Intervention