MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN OX CONSTRAINED FEM 6 RT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71421176
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Medical device site infection (4845)
Date of Event	05/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after a tka surgery was performed on (b)(6) 2022 the patient presented a periprosthetic infection and a revision surgery was performed.No further information available at this moment.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
Results of investigation: the devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, per complaint details, a revision total knee arthroplasty was performed due to a periprosthetic infection.As of the date of this medical investigation, the requested clinical documentation has not been provided for evaluation.It has been communicated via email correspondence within the attachments that further information is unavailable.Therefore, there were no clinical factors found which would have contributed to the reported infection.The patient impact beyond the revision surgery could not be determined.No further clinical assessment is warranted at this time.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 devices 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 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 these products and events.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 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.Corrected data: b1 (type of event), h6 (health effect - clinical code).

• Brand Name: LGN OX CONSTRAINED FEM 6 RT
• 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: 17061657
• Report Number: 1020279-2023-01224
• Device Sequence Number: 12056639
• Product Code: JWH
• UDI-Device Identifier: 03596010543929
• UDI-Public: 03596010543929
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K043440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71421176
• Device Catalogue Number: 71421176
• Device Lot Number: 22BM08161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2023
• Supplement Date Received by Manufacturer: 08/10/2023
• Initial Report FDA Received Date: 06/05/2023
• Supplement Report FDA Received Date: 08/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2022
• 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: PN: 71420523 / LOT: C2149066; PN: 71424014 / LOT: 20LM04122
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Unknown