MAUDE Adverse Event Report: SMITH & NEPHEW, INC. POROUS TIBIAL TRAY SIZE 5-RIGHT MEDIAL; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, UNICOMPARTMENTAL/UNICONDYLAR,

Catalog Number	1-10012-550
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	01/10/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a right unicompartmental knee arthroplasty combined with an acl reconstruction had been performed on (b)(6) 2020, the patient experienced the rupture of the acl graft.To treat this adverse event, an additional surgery and conversion to a tka was performed on (b)(6) 2022 due to global knee instability.During this procedure, all the uka devices from the construct were explanted and reported to be well-fixed.The patient's outcome is unknown.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, based on the information provided, we are unable to rule out a procedural variance as a contributing factor of the unicompartmental knee arthroplasty (uka) components to the failure of the anterior cruciate ligament (acl) graft which does not represent a device malfunction.Based on the engage instructions for use (ifu), this could be considered off label use.Engage ifu warns; ¿surgeon should implant this system in a patient with sufficient intact soft tissues and intact collateral and cruciate ligaments.¿ it cannot be concluded this was a failure of the uka components or a need to revise due to failure of the acl graft.The impact to the patient beyond that which has already been reported cannot be confirmed nor concluded.Should any additional relevant supporting clinical documentation be provided, this case would be re-assessed.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 risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that a similar event was identified and determined that the primary root cause is insufficient surgeon and medical education training program.Furthermore, there were limited resources available to engage to complete a more detailed surgeon training program.The following actions will be performed: build robust sales training and medical education program for engage products, deliver training to active surgeon users and hold quarterly surgeon training events.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but not limited to surgical technique used or user/procedural variance.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
Additional information: h7, h10.H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The photographs were reviewed, did not reveal any defects.The clinical/medical investigation concluded that, based on the information provided, we are unable to rule out a procedural variance as a contributing factor of the unicompartmental knee arthroplasty (uka) components to the failure of the anterior cruciate ligament (acl) graft which does not represent a device malfunction.Based on the engage instructions for use (ifu), this could be considered off label use.Engage ifu warns; ¿surgeon should implant this system in a patient with sufficient intact soft tissues and intact collateral and cruciate ligaments.¿ it cannot be concluded this was a failure of the uka components or a need to revise due to failure of the acl graft.The impact to the patient beyond that which has already been reported cannot be confirmed nor concluded.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 and for the batch number based on historical data of the device did not reveal similar events for the listed device.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 product specifications at the time of manufacture.Factors that could contribute to the reported event include surgical technique used or user/procedural variance.Based on this investigation, the need for corrective action may be indicated.

• Brand Name: POROUS TIBIAL TRAY SIZE 5-RIGHT MEDIAL
• 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: 14342009
• Report Number: 1020279-2022-02262
• Device Sequence Number: 12009537
• Product Code: NJD
• UDI-Device Identifier: 00885556873205
• UDI-Public: 885556873205
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K190439
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Other,Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/03/2023

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: 03/09/2025
• Device Catalogue Number: 1-10012-550
• Device Lot Number: 100051
• 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: 04/10/2022
• Supplement Date Received by Manufacturer: 06/10/2022; 06/30/2023
• Initial Report FDA Received Date: 05/09/2022
• Supplement Report FDA Received Date: 06/13/2022; 07/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2020
• 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: TIBIAL ANCHOR STEM SIZE 5-6-100071.
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Sex: Male