MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION PS OXIN FEM SZ7 RT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71453221
Medical Device Problem Codes	Loss of Osseointegration (2408); Osseointegration Problem (3003); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Cyst(s) (1800); Failure of Implant (1924); Inflammation (1932); Synovitis (2094); Inadequate Osseointegration (2646)
Date of Event	06/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after a tka surgery where a legion femoral and insert component, and a genesis ii tibial component were implanted, a revision had to be performed, due to early knee prosthesis loosening with inflammatory reaction (synovitis) and an intraosseous cyst formation (loss of substance).During the revision surgery, a new total knee prosthesis was fitted and a bone graft was performed.No other complications were reported.Patient's current health status is unknown.
Additional Manufacturer Narrative
Additional information: h6 (component code, type of investigation, investigation findings, investigation conclusions).Results of investigation: the associated devices were returned and evaluated.The reported event was analyzed.A visual inspection of the returned oxinium femoral component reveals scratches in the surface of the device and dried bone cement still on the implant.Two additional devices were returned.The tibial baseplate reveals scratches and signs of wear and the insert reveals signs of wear, scratches and gouges in the surface of the device.A review of complaint history revealed similar events for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.The clinical/medical evaluation concluded that this case reports a revision tka almost six years post implantation due to early loosening with synovitis and intraosseous cyst formation.During the procedure, a new total knee prosthesis was implanted and bone graft was performed.As of the date of this medical investigation, the requested clinical documentation has not been provided for evaluation.Therefore, there were no clinical factors found which would have contributed to the reported event.The patient impact beyond the revision surgery is not anticipated as the patient¿s current health status was reported to be good.No further clinical/medical assessment can be rendered at this time.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management and information for use files revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.A review of instructions for use for knee system revealed that looseness of components has been identified in possible adverse effects section as a result from trauma, improper implant selection, improper implant positioning, improper fixation, and/or migration of the components.Muscle and fibrous tissue laxity can also contribute to these conditions.Factors that could contribute to the reported event include abnormal motion over time, bone degeneration, osteolysis and/or traumatic injury.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor future complaints and investigate as necessary.We consider this investigation closed.Corrected data: b1 (type of event), h3 (device returned for analysis), h6 (health effect - clinical code, medical device problem code).
Event or Problem Description
It was reported that, after a right tka surgery was conducted on (b)(6) 2017 where a legion femoral and insert component, and a genesis ii tibial component were implanted, a revision was performed on (b)(6) 2023 due to early knee prosthesis loosening with inflammatory reaction (synovitis) and an intraosseous cyst formation (loss of substance).The patient presented with a gap in the right distal femur with loosening of the femoral implant.During the revision surgery, a new total knee prosthesis was fitted and a bone graft was performed.No other complications were reported.Patient's current health status was reported to be good.

• Brand Name: LEGION PS OXIN FEM SZ7 RT
• 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: 17303064
• Report Number: 1020279-2023-01442
• Device Sequence Number: 15072397
• Product Code: JWH
• UDI-Device Identifier: 00885556029404
• UDI-Public: 00885556029404
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K043440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/10/2023

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: 71453221
• Device Catalogue Number: 71421207
• Device Lot Number: 17BM12024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2023
• Supplement Date Received by Manufacturer: 07/13/2023; 08/09/2023
• Initial Report FDA Received Date: 07/11/2023
• Supplement Report FDA Received Date: 07/27/2023; 08/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2017
• 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: GNS II BCNVX PAT 26MM(PN:71420568,LN:17AM20756); GNS II BICONVEX PAT 26MM, LOT#:17AM20756; GNS II CMT TIB SIZE 6 RIGHT, LOT#:J1710782; GNS II CMT TIB SZ 6 RT(PN:71420188,LN:J1710782); LEGION PS OXIN FEM SZ7 RT, LOT#:17BM12024; LGN PS HFL XL SZ 5-6 9MM(PN:71453221,LN:17ET88015)
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 65 YR
• Patient Sex: Male