MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION CR OXIN FEM SZ3 LT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71421233
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Rupture (2208); Deformity/ Disfigurement (2360); Muscle/Tendon Damage (4532); Insufficient Information (4580)
Date of Event	05/31/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after tka surgery had been performed on (b)(6) 2022 using a legion+genesis system, the patient experienced a patellar tendon rupture.The patient underwent two arthroscopies to resolve this adverse event.On (b)(6) 2023, after several follow-ups, the patient had an open biopsy and puncture due to a suspected periprosthetic infection.No further complications were reported, and the infection couldn't be confirmed.
Additional Manufacturer Narrative
Additional information: h6 (component code, type of investigation, investigation findings, investigation conclusions).Results of investigation: given the nature of the alleged incident, the devices were not returned for evaluation.The clinical/medical investigation concluded that, the provided undated, unlabeled x-ray photos confirm the various stages of the injury and related repair.Based on the information provided, the reported fall was the likely cause of the reported patellar tendon rupture.Although we cannot rule out the patient¿s gonarthrosis, mild obesity, the duration and intensity of postoperative rehabilitation, potential inflammatory process as noted with the reported leukocyte level, poor compliance to postoperative rehabilitation or a combination of all as contributing factors to the subsequent open revisions, open biopsy and puncture.The instructions for use for knee systems does warn, ¿protected weight bearing with external support is recommended for a period to allow healing.Normal daily activity may be resumed at the physician¿s direction.Patients should be directed to seek medical opinion before entering potentially adverse environments that could affect the performance of the implant.¿ consequently, it cannot be concluded that the reported adverse event is related to a mal performance of the implant or implant failure.On the day of discharge, it was reported the patient¿s suspected periprosthetic infection of the left knee joint was not confirmed and the wound and soft tissue conditions were dry and free of irritation with wound closure material still in place.Therefore, impact beyond the reported fall, the two open-revisions, the open biopsy and puncture cannot be confirmed nor concluded.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 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.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 traumatic injury, patient medical history and/or patient condition.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: g2 (report source updated), h6 (health effect - clinical code, health effect - impact code).

• Brand Name: LEGION CR OXIN FEM SZ3 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: 17292956
• Report Number: 1020279-2023-01411
• Device Sequence Number: 6226150
• Product Code: JWH
• UDI-Device Identifier: 00885556030240
• UDI-Public: 00885556030240
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K043440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2023

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: 71421233
• Device Catalogue Number: 71421233
• Device Lot Number: 19JM07692
• 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: 06/12/2023
• Supplement Date Received by Manufacturer: 08/03/2023
• Initial Report FDA Received Date: 07/10/2023
• Supplement Report FDA Received Date: 08/04/2023
• Date Device Manufactured: 09/11/2019
• 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 1-2 13MM, LOT#:19CT18625; GNS II CMT TIB SIZE 2 {} LEFT, LOT#:J2137690; GNS II RESURF PAT 29MM, LOT#: 21KM00553
• Outcome Attributed to Adverse Event: Other
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 89 KG