MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION CR OXIN FEM SZ4 LT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71421234
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after a tka revision surgery was performed due to infection on (b)(6) 2023, the infection did not calm down.This adverse event was solved with a 2nd revision surgery performed on (b)(6) 2023, in which all implants (gii dished ins sz 3-4 11mm, legion cr oxin fem sz4 lt, gns ii cmt tib size 4 left and gns ii resurf pat 26mm), were removed and cement mold was implanted.Health status of patient is unknown.
Additional Manufacturer Narrative
H3, h6: the devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, 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 subsequent second revision cannot be determined.The patient¿s current health status is unknown.Therefore, no further clinical/medical assessment can be rendered at this time.Should any additional relevant medical information be provided, this case would be re-assessed.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 device.A review of the instructions for use documents for knee systems revealed that acute post-surgical wound infection has been identified in possible adverse effects.Active, local infection or previous intra-articular infections are identified in 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 this product and event.A review of the sterilization records revealed the batch was sterilized within normal parameters.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include loss of sterility during procedure, patient reaction, and post-operative healing issue.Based on this investigation, the need for corrective action is not indicated.Should the devices or 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: LEGION CR OXIN FEM SZ4 LT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• 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: 16383376
• Report Number: 1020279-2023-00348
• Device Sequence Number: 20105422
• Product Code: JWH
• UDI-Device Identifier: 00885556030912
• UDI-Public: 00885556030912
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K043440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2023

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 Expiration Date: 07/06/2023
• Device Model Number: 71421234
• Device Catalogue Number: 71421234
• Device Lot Number: 13GM04064
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2023
• Supplement Date Received by Manufacturer: 03/22/2023
• Initial Report FDA Received Date: 02/15/2023
• Supplement Report FDA Received Date: 03/23/2023
• Date Device Manufactured: 07/08/2013
• 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: GII DISHED INS SZ 3-4 11MM, LOT#:19KM19854; GNS II CMT TIB SIZE 4 LEFT, LOT#: 13ET31141; GNS II RESURF PAT 26MM, LOT#: 13DM05903
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown