MAUDE Adverse Event Report: SMITH AND NEPHEW, INC. LEGION CR OXIN FEM SZ3 RT; PRSTHSS, KNEE, PTLLFMRTBIAL, SM-CNSTRND, CMNTD, POLYMER/METAL/POLYMER

Catalog Number	71421223
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/19/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to instability and loosening of the implant.
Additional Manufacturer Narrative
The affected genesis ii cmt tibial baseplate, legion cr oxinium femoral component and legion dished insert were not returned for evaluation.A clinical analysis noted that details regarding the patient¿s weight-bearing status, medical history, bone quality, fall/trauma history, and other additional clinical relevant information have not been provided.However, given that the surgical report states there was posterior instability in flexion and slight varus-valgus instability, this was likely the cause of the patient¿s pain.Based on the limited information provided and without the return of the device for evaluation the root cause of the reported component instability cannot be concluded.Our investigation including a review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.Without the return of the actual product involved, our investigation of this report is inconclusive.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: LEGION CR OXIN FEM SZ3 RT
• Common Device Name: PRSTHSS, KNEE, PTLLFMRTBIAL, SM-CNSTRND, CMNTD, POLYMER/METAL/POLYMER
• Manufacturer (Section D): SMITH AND NEPHEW, INC.; 1450 brooks road; memphis, tennessee; memphis 38116
• MDR Report Key: 7926933
• Report Number: 1020279-2018-01864
• Device Sequence Number: 16542792
• Product Code: JWH
• UDI-Device Identifier: 00885556029718
• UDI-Public: 00885556029718
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K043440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2019

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 Expiration Date: 01/19/2025
• Device Catalogue Number: 71421223
• Device Lot Number: 15AM14597
• Initial Date Received by Manufacturer: 09/05/2018
• Supplement Date Received by Manufacturer: 09/05/2018
• Initial Report FDA Received Date: 10/02/2018
• Supplement Report FDA Received Date: 04/06/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 59 YR