MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION CR OXIN FEM SZ5 LT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71421235
Medical Device Problem Codes	Biocompatibility (2886); Scratched Material (3020)
Health Effect - Clinical Codes	Infiltration into Tissue (1931); Loss of Range of Motion (2032); Arthralgia (2355)
Date of Event	12/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a tka had been performed on (b)(6) 2022 with a legion system, the patient experienced pain, stiffness, and elevated oxinium levels.A revision surgery was conducted on (b)(6) 2022.Intraoperatively, the legion croxin fem sz5 lt was discovered to be very scratched up and damaged, while the lgn xlpe dished isrt sz 7-8 9mm had pieces of metal embedded in the surface.It is unknown what the current health status of the patient is.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H3, h6: the devices were not returned for evaluation.However, the photographs were reviewed, and revealed that the legion cruciate retaining oxinium femoral size 5 left shows scratches and the legion xlpe dished insert size 7-8 9mm appears to have pieces of metal in the surface.However, the clinical/medical investigation concluded that, per complaint details, a revision was performed approximately 10 months post implantation due to ¿pain, stiffness, and elevated oxinium levels¿.Reportedly, during the revision, the legion oxinium femoral component was discovered to be ¿very scratched up and damaged¿ , while the legion xlpe dished insert ¿had pieces of metal embedded in the surface.It is unknown what the current health status of the patient is¿ or if the patient experienced any trauma prior to onset of reported symptoms.The three electronic photo images provided appear to show scant dark flecks/particulate on the insert surface (with probable bloody residue), as well as bilateral deformation of the oxinium femoral condyles/articulating surface which can been seen with, and/or may represent, third body wear due to presence of bone, bone cement and/or other foreign body particulate within the articulating bearing space.As of the date of this medical investigation, no operative notes, x-rays, or lab results have been provided.All documents and images provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical/medical investigation.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 in possible adverse effects that wear of the polyethylene articulating surfaces of knee replacement components has been reported following total knee replacement.Higher rates of wear may be initiated by particles of cement, metal, or other debris which can cause abrasion of the articulating surfaces.Higher rates of wear may shorten the useful life of the prosthesis, and lead to early revision surgery to replace the worn prosthetic components.Additionally, warnings and precautions section establish that extreme care in patient handling is needed and postoperative patient care, directions and warnings to patients by physicians are extremely important.Patients should be directed to seek medical opinion before entering potentially adverse environments that could affect the performance of the implant.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 product specifications at the time of manufacture.With the results of this investigation the root cause of this event could not be determined.Factors that could contribute to the reported event include friction, joint tightness, irregular implant interaction, wear 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.

• Brand Name: LEGION CR OXIN FEM SZ5 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: 16095638
• Report Number: 1020279-2023-00033
• Device Sequence Number: 6703811
• Product Code: JWH
• UDI-Device Identifier: 00885556029176
• UDI-Public: 00885556029176
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K043440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2023

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: 71421235
• Device Catalogue Number: 71421235
• Device Lot Number: 21GM21056
• 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: 12/09/2022
• Supplement Date Received by Manufacturer: 01/26/2023
• Initial Report FDA Received Date: 01/04/2023
• Supplement Report FDA Received Date: 01/27/2023
• Date Device Manufactured: 07/30/2021
• 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: LGN XLPE DISHED ISRT SZ 7-8 9MM, LOT#:21JM18773
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 52 YR
• Patient Sex: Male