MAUDE Adverse Event Report: SMITH & NEPHEW, INC. POROUS FEMORAL COMP SIZE 6-RIGHT MEDIAL; PROSTHE, KNEE, FEMO, SEMI-CONS, UNICOM/UNICOR, UNCEM, POROUS-COATED, METAL/POLY

Catalog Number	1-10003-600
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Pain (1994); Arthralgia (2355); Inadequate Osseointegration (2646)
Date of Event	03/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after an unicompartmental knee arthroplasty had been performed on (b)(6) 2021, the patient experienced persistent pain and loosening of the femoral component.A revision surgery was performed on (b)(6) 2022 to treat this adverse event.During this procedure, the surgeon revised the femoral component to a new engage cemented femoral component.Intraoperatively, the surgeon found a minimal bony-ingrowth on the original femoral component, making it relatively easy to remove without much bone loss.The patient's outcome is unknown.
Additional Manufacturer Narrative
Internal complaint reference number: (b)(4).
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation.The picture provided was reviewed and could not confirm the stated failure mode.The clinical/medical investigation concluded that, without the requested clinical information, a thorough medical investigation cannot be rendered.One photo of the removed explant was provided for review however it does not indicate a root cause for the reported pain and loosening.The patient's current condition is unknown and the patient impact beyond the reported events could not be determined based on the limited information provided.Should any additional clinical information be provided this complaint will be re-evaluated.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the instructions for use documents for engage partial knee system revealed that early or late loosening of prosthetic have been identified as adverse effects and complications and can occur as a result of an incorrect fixation or positioning of the components and that it can cause pain, dislocation, subluxation, flexion contracture, mobility reduction, leg shortening or lengthening.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are prior actions related to this product and event: corrective and preventive actions are being performed to reduce the risk of a revision surgery from happening.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors and/or some potential probable causes that could contribute to the reported event have been identified as abnormal motion over time, bone degeneration, fit/sizing issue, lack of ingrowth, lifetime of device, and/or traumatic injury.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
Additional Manufacturer Narrative
Section h3, h6: the device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, without the requested clinical information, a thorough medical investigation cannot be rendered.One photo of the removed explant was provided for review however it does not indicate a root cause for the reported pain and loosening.The patient's current condition is unknown and the patient impact beyond the reported events could not be determined based on the limited information provided.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 for the part and batch number did not reveal similar events for the listed device.A review of the instructions for use documents for engage partial knee system revealed in the adverse effects and complications section that early or late loosening of prosthetic can occur as a result of an incorrect fixation or positioning of the components and that it can cause pain, dislocation, subluxation, flexion contracture, mobility reduction, leg shortening or lengthening.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, loss of ingrowth, osteolysis and/or traumatic injury.Based on this investigation, the need for corrective action may be indicated.

• Brand Name: POROUS FEMORAL COMP SIZE 6-RIGHT MEDIAL
• Common Device Name: PROSTHE, KNEE, FEMO, SEMI-CONS, UNICOM/UNICOR, UNCEM, POROUS-COATED, METAL/POLY
• 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: 14227588
• Report Number: 1020279-2022-02003
• Device Sequence Number: 17220925
• Product Code: NJD
• UDI-Device Identifier: 00885556873021
• UDI-Public: 885556873021
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K190439
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/01/2023

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: Lay User/Patient
• Device Catalogue Number: 1-10003-600
• Device Lot Number: 100035
• 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: 04/04/2022
• Supplement Date Received by Manufacturer: 06/10/2022; 05/30/2023
• Initial Report FDA Received Date: 04/27/2022
• Supplement Report FDA Received Date: 06/14/2022; 06/01/2023
• 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: RES 92286
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: POROUS TIBIAL TRAY SIZE 4-RIGHT MEDIAL; TIBIAL ANCHOR STEM SIZE 3-4; TIBIAL INSERT SIZE 4-RIGHT MED 9MM
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown