MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION PS OXIN FEM SZ5 RT; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED,CEMENTED,POLYMERMETAL

Model Number	71421205
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994)
Date of Event	10/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference case (b)(4).
Event or Problem Description
It was reported that, after a tka surgery performed on (b)(6) 2021, the patient complained of knee pain during his follow up on (b)(6) 2021.The doctor reviewed and out that there is fracture line on the bone where the legion posterior stabilized oxonium femoral size 5 right was implanted.Current health state of the patient is unknown.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, the doctor is not willing to disclose certain clinical/medical documentation.Smith and nephew has not received the explanted device and/or adequate materials to fully evaluate the complaint.If additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history did not reveal similar events for the listed device.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.The instructions for use documents revealed this failure mode was previously identified.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but not limited to traumatic injury, joint tightness or excessive forces applied to implant.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device 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.B5.
Event or Problem Description
It was reported that, after a tka surgery performed on 18-oct-2021, the patient complained of knee pain during his follow up on 29-oct-2021.The doctor reviewed and out that there is fracture line on the bone where the legion posterior stabilized oxinium femoral size 5 right was implanted.Currently patient has knee discomfort.

• Brand Name: LEGION PS OXIN FEM SZ5 RT
• Common Device Name: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED,CEMENTED,POLYMERMETAL
• 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: 12829571
• Report Number: 1020279-2021-08213
• Device Sequence Number: 19192847
• Product Code: JWH
• UDI-Device Identifier: 00885556030622
• UDI-Public: 00885556030622
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K043440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2022

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: 71421205
• Device Catalogue Number: 71421205
• Device Lot Number: 21EM07466
• 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: 10/29/2021
• Supplement Date Received by Manufacturer: 02/16/2022
• Initial Report FDA Received Date: 11/17/2021
• Supplement Report FDA Received Date: 02/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/11/2021
• 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
• Patient Age: 56 YR
• Patient Sex: Male