MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ENGAGE POROUS FEMORAL SZ 4-LT MED; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, UNICOMPARTMENTAL/UNICONDYLAR,

Catalog Number	1-10003-410
Medical Device Problem Codes	Osseointegration Problem (3003); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Inadequate Osseointegration (2646)
Date of Event	09/15/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after a pka surgery with the engage cementless partial knee system, the patient experienced a knee loosening.This adverse event was solved by revision surgery on (b)(6) 2022.Current health status of patient in unknown.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation; therefore, a device analysis could not be performed.The shipping information was provided and all efforts were made to locate the device but we have no evidence that it was ever received by the complaint investigation team for evaluation.The clinical/medical investigation concluded that, as of the date of this medical investigation, the requested clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the event.Based on a review of the information provided, the root cause and/or patient impact beyond that which was documented in the complaint could not be confirmed nor concluded.Therefore, no further medical assessment can be rendered at this time.Device specific identifiers were not provided.Therefore, an evaluation of the production records and complaint history review could not be performed.A review of the instructions for use documents for engage partial knee system revealed in the adverse effects and complications section that loosening or wear of one or more of the prosthetic components is often related to the risk factors identified in this document.Loosening can also occur as a result of an incorrect fixation or positioning of the components and pain as a result of improper positioning, loosening or wear of the components.Also, damaged fixation or implant loosening may happen as a result of bone resorption.There is not enough data available to conclude that the overall clinical benefit outweighs the potential risk profile when compared to the state of the art.The existing data identifies a potential signal that the performance is an outlier vs the state of the art with respect to the risk for revision.In addition, a historical review concluded that no previous escalated actions for this type of issue were identified.However, as a correction action a voluntary market removal will be performed for the engage cementless partial knee system due recent complaint data that indicates that the revision rate may be trending higher than corresponding similar devices in global joint replacement registries.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include abnormal motion over time, bone degeneration, size selected, inadequate integration between the cement and bone/implant, osteolysis and/or traumatic injury.Based on this investigation, the need for corrective action may be indicated.
Additional Manufacturer Narrative
Additional information: a1, a2, a3, b5, d1, d4, d10, h6 (health effect - clinical code).
Event or Problem Description
It was reported that, after a left pka surgery with the engage cementless partial knee system, the patient experienced a femur loosening.This adverse event was solved by revision surgery on (b)(6) 2022.Current health status of patient in unknown.
Additional Manufacturer Narrative
H11.Corrected information in h6 (medical device problem code).
Additional Manufacturer Narrative
Additional information: h6, h9, h10.H3, h6: the devices were not returned for evaluation; therefore, a device analysis could not be performed.The shipping information was provided and all efforts were made to locate the devices but we have no evidence that it was ever received by the complaint investigation team for evaluation.The clinical/medical investigation concluded that, based on the limited information provided, the definitive clinical root cause of the reported left tibia and femur loosening could not be determined.Although, we cannot rule out the patient¿s age and history of osteoarthritis as contributing factors.It is unknown if the instructions for use document was adhered to.The patient impact beyond the reported revision could not be determined since the current health status is unknown.The devices' batch numbers were not provided, thus, an evaluation of the manufacturing records could not be performed.A review of complaint history based on the historical data revealed similar previous events, however, no commonalities that would suggest a device deficiency were found.A review of the instructions for use documents for engage partial knee system revealed that loosening or wear of one or more of the prosthetic components is often related to the risk factors identified in this document.Loosening can also occur as a result of an incorrect fixation or positioning of the components and pain as a result of improper positioning or wear of the components.Also, damaged fixation or implant loosening may happen as a result of bone resorption.There is not enough data available to conclude that the overall clinical benefit outweighs the potential risk profile when compared to the state of the art.The existing data identifies a potential signal that the performance is an outlier vs the state of the art with respect to the risk for revision.In addition, a historical review concluded that no previous escalated actions for this type of issue were identified.However, as a correction action a voluntary market removal will be performed for the engage cementless partial knee system due recent complaint data that indicates that the revision rate may be trending higher than corresponding similar devices in global joint replacement registries.At this time, we have no evidence to conclude that the products failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include abnormal motion over time, bone degeneration, size selected, lack or loss of ingrowth, osteolysis and/or traumatic injury.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: ENGAGE POROUS FEMORAL SZ 4-LT MED
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, UNICOMPARTMENTAL/UNICONDYLAR,
• 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: 16437031
• Report Number: 1020279-2023-00409
• Device Sequence Number: 3126974
• Product Code: NJD
• UDI-Device Identifier: 00885556872994
• UDI-Public: 885556872994
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K190439
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 10/01/2024

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 Catalogue Number: 1-10003-410
• Device Lot Number: UNKNOWN
• 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: 09/15/2022
• Supplement Date Received by Manufacturer: 05/24/2023; 08/01/2024; 09/27/2024; 09/27/2024; 09/27/2024
• Initial Report FDA Received Date: 02/24/2023
• Supplement Report FDA Received Date: 05/30/2023; 08/09/2024; 09/27/2024; 09/29/2024; 10/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1670-2023
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 1-10013-109/TIBIAL INSERT SIZE 1-LEFT MED 9MM
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Male