MAUDE Adverse Event Report: SMITH & NEPHEW, INC. POROUS TIBIAL TRAY SIZE 3-RIGHT MEDIAL; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, UNICOMPARTMENTAL/UNICONDYLAR,

Catalog Number	1-10012-350
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Arthralgia (2355); Deformity/ Disfigurement (2360)
Date of Event	01/04/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: case (b)(4).
Event or Problem Description
It was reported that, after a cementless right unicompartmental knee arthroplasty had been performed on (b)(6) 2021, the patient start experiencing pain 6 months postoperatively.The patient insistently requested the surgeon to revise her right knee to a tka system, despite the surgeon being satisfied with the implant positioning and the recovery process.X-rays taken after primary implantation appear to reveal a slight valgus con the tibial tray cut.A revision surgery was performed on (b)(6) 2022.During this procedure, all devices from the construct were explanted and intraoperatively, the were noted to be well fixed.The patient's outcome is unknown.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation but the pictures were reviewed and did not reveal any failure on the devices.However, the valgus was confirmed.The clinical/medical investigation concluded that, a report of slight valgus of the tibial tray cut is related to the procedure and not the implant.It is unknown to what extent it had on the reported pain.Based on the information provided, we cannot rule out early bone remodeling as the contributing factor to the patient¿s start-up pain as the implants were noted to be in good alignment and well fixed.The patient impact beyond that which has already been reported cannot be determined.No further clinical/medical assessment is warranted 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.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 pain, dislocation, subluxation, flexion contracture, mobility reduction, leg shortening or lengthening, resulting from improper positioning, loosening or wear of the components has been identified as a adverse effects and complications.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 for the same device, but they cannot be linked to the complaint device.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 joint tightness, material in use, patient reaction, surgical technique used, size of device or user/procedural variance.The contribution of the device to the reported event could be corroborated since a revision surgery was required.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
The device was not returned for evaluation; therefore, a device analysis could not be performed.The photographs were reviewed, and revealed that the device shows signs of use.The clinical/medical investigation concluded that, a report of slight valgus of the tibial tray cut is related to the procedure and not the implant.It is unknown to what extent it had on the reported pain.Based on the information provided, we cannot rule out early bone remodeling as the contributing factor to the patient¿s start-up pain as the implants were noted to be in good alignment and well fixed.The patient impact beyond that which has already been reported cannot be determined.No further clinical/medical assessment is warranted 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 did not revealed similar previous events for the listed part and batch number.A review of the instructions for use documents for engage partial knee system revealed that pain, dislocation, subluxation, flexion contracture, mobility reduction, leg shortening or lengthening, resulting from improper positioning, loosening or wear of the components, have been identified in adverse effects and complications.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.

• Brand Name: POROUS TIBIAL TRAY SIZE 3-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: 14341772
• Report Number: 1020279-2022-02259
• Device Sequence Number: 5198898
• Product Code: NJD
• UDI-Device Identifier: 00885556873168
• UDI-Public: 885556873168
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/26/2023

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: 05/07/2025
• Device Catalogue Number: 1-10012-350
• Device Lot Number: 100059
• 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: 06/21/2022; 06/22/2023
• Initial Report FDA Received Date: 05/09/2022
• Supplement Report FDA Received Date: 06/22/2022; 06/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2020
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1672-2023
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: POROUS FEMORAL COMP SIZE 3-RIGHT MEDIAL-100022.; TIBIAL ANCHOR STEM SIZE 3-4-100070.; TIBIAL INSERT SIZE 3-RIGHT MED 9MM-100086.
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 68 KG