MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN POR CR HA FEM SZ 7 RIGHT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	71425217
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/03/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that after a tka surgery was performed on (b)(6) 2023, the patient presented an infection and a revision surgery had to be performed on (b)(6) 2023.Current health status of the patient reported as good.No further information available.
Additional Manufacturer Narrative
The associated devices were returned and evaluated.The visual inspection of the returned femoral revealed some bone cement and signs of wear.The visual for the insert revealed scratches and gouges in the surface of the device.The visual of the tibial baseplate revealed scratches and discoloration.All devices show signs of wear.The clinical/medical investigation concluded that, per case details, the patient underwent a revision due to an unspecified infection approximately two (2) weeks after a right total knee arthroplasty surgery was performed.A review of the four provided photos appears to show the returned tibial baseplate, femoral component and poly insert; however, the images do not provide insight into the reported infection.As of the date of this medical investigation, the requested clinical documentation has not been provided; therefore, there were no clinical factors found which would have definitively contributed to the event.The patient impact beyond the reported infection and revision cannot be determined and patient¿s current health status is reportedly good.Therefore, no further clinical/medical assessment can be rendered.A review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part numbers over the past 12 months and for the batch numbers based on historical data of the device did not reveal similar events for the listed devices.A review of the instructions for use documents for knee systems revealed that acute post-surgical infection and active, local infection or previous intra-articular infections have been identified as possible adverse effects and contraindications for total knee replacement.A review of the risk management files revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to these products and event.A review of the sterilization records revealed the batches were sterilized within normal parameters.At this time, we have no reason to suspect that the products failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include loss of sterility during procedure, post-operative healing issue, injury, patient condition and/or medical history.Based on this investigation, the need for corrective action is not indicated.Should 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.

• Brand Name: LGN POR CR HA FEM SZ 7 RIGHT
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 16792424
• Report Number: 1020279-2023-00906
• Device Sequence Number: 17562596
• Product Code: MBH
• UDI-Device Identifier: 00885556108482
• UDI-Public: 00885556108482
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K091543
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2023

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: 71425217
• Device Catalogue Number: 71425217
• Device Lot Number: 20KHA0030D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2023
• Supplement Date Received by Manufacturer: 06/19/2023
• Initial Report FDA Received Date: 04/21/2023
• Supplement Report FDA Received Date: 06/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 71425306 / LOT NUMBER 22GM13239.; 71425346 / LOT NUMBER 21MM01558.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown