MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ENGAGE POROUS FEMORAL SZ 4-RT MED; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	1-10003-400
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Arthralgia (2355); Inadequate Osseointegration (2646)
Date of Event	03/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after an ukr surgery was performed in june of 2022 using an engage system, the patient had persistent pain.A revision surgery was performed on (b)(6) 2023, on which the engage porous femoral sz 4-rt med device was found to be relatively loose with just fibrous on-growth.Current health status of patient is unknown.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H10: additional information in d9.H11: corrected information in d4 (lot # and exp date) and h4.
Additional Manufacturer Narrative
Additional information: d10.H3, h6: the associated devices were returned and evaluated.The visual inspection revealed gouges and scratches on the devices.The devices show signs of wear.The clinical/medical investigation concluded that, as of the date of this medical investigation, the supporting clinical documentation has not been provided.A loosened femoral component was reportedly found during the revision; therefore, cannot be ruled out as the contributing factor to the revision; however, a definitive clinical root cause of the lack of bony on-growth cannot be concluded.The patient impact beyond the reported pain, loosened component and subsequent revision cannot be determined.No further medical assessment could be rendered at this time.A review of the production records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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 that pain can result from improper positioning, loosening or wear of components.Besides, loosening can occur as a result of an incorrect fixation or positioning of the components.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 traumatic injury, joint tightness, patient condition or postoperative care.Based on this investigation, the need for corrective action may be indicated.
Additional Manufacturer Narrative
The associated device was returned and evaluated.The visual inspection revealed gouges and scratches on the devices.The devices show signs of wear.A lab analysis performed on the devices revealed that the femoral component, insert, and tibial baseplate are all worn.The porous bone contacting surfaces of the femoral and tibial baseplate components still have substance adhered to them.The anchor stem is damaged and still connected to the tibial baseplate.There were no observations of material or manufacturing deviations in the course of this investigation.The clinical/medical investigation concluded that, as of the date of this medical investigation, the supporting clinical documentation has not been provided.A loosened femoral component was reportedly found during the revision; therefore, cannot be ruled out as the contributing factor to the revision; however, a definitive clinical root cause of the lack of bony on-growth cannot be concluded.The patient impact beyond the reported pain, loosened component and subsequent revision cannot be determined.No further medical assessment could be rendered at this time.A review of the production records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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 pain can result from improper positioning, loosening or wear of components.Besides, loosening can occur as a result of an incorrect fixation or positioning of the components.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 traumatic injury, joint tightness, patient condition or postoperative care.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: ENGAGE POROUS FEMORAL SZ 4-RT MED
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• 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: 16735882
• Report Number: 1020279-2023-00824
• Device Sequence Number: 6862329
• Product Code: HSX
• UDI-Device Identifier: 00885556872987
• UDI-Public: 885556872987
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K190439
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall,Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/03/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/12/2026
• Device Catalogue Number: 1-10003-400
• Device Lot Number: 100225
• 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: 03/20/2023
• Supplement Date Received by Manufacturer: 04/18/2023; 06/29/2023; 09/29/2023
• Initial Report FDA Received Date: 04/13/2023
• Supplement Report FDA Received Date: 04/27/2023; 07/03/2023; 10/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2021
• 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
• 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: 1-10011-300/ENGAGE TIBIAL ANCHOR STEM SZ 5-6; 1-10012-550/ENGAGE POROUS TIBIAL TRAY SZ 5-RT MED; 1-10013-559/ENGAGE TIBIAL INSERT SZ 5-RT MED 9MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown