MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION PS OXIN FEM SZ6 LT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/META

Catalog Number	71421216
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/07/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the clinical subject experienced decreased range of motion on the study knee.The event was treated via surgery and is considered resolved.
Additional Manufacturer Narrative
Results of investigation: it was reported that the clinical subject experienced decreased range of motion on the study knee.The affected complaint device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.A review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A relationship, if any, between the device and the reported incident could not be corroborated.Based on this investigation, the need for corrective action is not indicated.A review of risk management files and the instructions for use found that the reported failure was documented appropriately.A medical analysis noted that the patient developed a painful secondary patellofemoral osteoarthritis.Patella tangential x-ray views in the time course are provided and show narrow joint space and change in angle of the patella as well as bone growth on the borders of the patella.Patient was advised to undergo secondary patellar resurfacing but has not made an appointment for that surgery.Instead, approximately 3 months post implantation the patient underwent an ¿arthroscopic arthrolysis¿ and the event is now documented as resolved.The impact to the patient beyond the second surgery cannot be determined.The root cause of the decrease range of motion 4 months post op could be scaring after the procedure.It does not appear to be a failure of the devices implanted.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.We consider this investigation closed.
Additional Manufacturer Narrative
Results of investigation: it was reported that the clinical subject experienced decreased range of motion on the study knee.The affected complaint device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.A review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A relationship, if any, between the device and the reported incident could not be corroborated.Based on this investigation, the need for corrective action is not indicated.A review of risk management files and the instructions for use found that the reported failure was documented appropriately.A medical analysis noted that the patient developed a painful secondary patellofemoral osteoarthritis.Patella tangential x-ray views in the time course are provided and show narrow joint space and change in angle of the patella as well as bone growth on the borders of the patella.Patient was advised to undergo secondary patellar resurfacing but has not made an appointment for that surgery.Instead, approximately 3 months post implantation the patient underwent an ¿arthroscopic arthrolysis¿ and the event is now documented as resolved.The impact to the patient beyond the second surgery cannot be determined.The root cause of the decrease range of motion 4 months post op could be scaring after the procedure.It does not appear to be a failure of the devices implanted.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: LEGION PS OXIN FEM SZ6 LT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/META
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10077423
• Report Number: 1020279-2020-01820
• Device Sequence Number: 3358498
• Product Code: JWH
• UDI-Device Identifier: 00885556030059
• UDI-Public: 885556030059
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K043440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/10/2021

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 Catalogue Number: 71421216
• Device Lot Number: 17MM02160
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/27/2020
• Supplement Date Received by Manufacturer: 12/11/2020; 04/13/2021
• Initial Report FDA Received Date: 05/20/2020
• Supplement Report FDA Received Date: 01/06/2021; 05/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 110