MAUDE Adverse Event Report: SMITH & NEPHEW, INC. POROUS TIBIAL TRAY SIZE 2-LEFT MEDIAL; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, UNICOMPARTMENTAL/UNICONDYLAR,

Catalog Number	1-10012-200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994); Arthralgia (2355); Deformity/ Disfigurement (2360)
Date of Event	03/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after an unicompartmental knee arthroplasty had been performed on (b)(6) 2021, the patient experienced postoperative pain 2 weeks after initial implantation.An anteroposterior x-ray showed a possible non-displaced fracture between sagittal cut and the implant, for which the surgeon decided to indicate non-weight bearing for 90 days to allow the patient heal as a fibrous union.As the pain continued 4 months postoperatively, the patient successfully underwent revision surgery on (b)(6) 2022 to a tka construct.The outcome of the patient is unknown.
Additional Manufacturer Narrative
Section h3, h6: the device was not returned for evaluation but the pictures were reviewed, and the bone weakening was confirmed.The clinical/medical investigation concluded that, per the complaint details, currently we are unable to rule out a procedural variance as a contributing factor to the reported event which does not represent a device malfunction.Based on the information provided, the surgeon conducted the surgical technique using another company¿s tibial cutting guide, this is considered off label per the engage ifu and stg.Additionally, per the engage ifu, it is contraindicated for use of fixed tibial deformities (tibia vara).Based on the information provided, the revision was successful, however, the patient¿s outcome was reported as unknown.Therefore, the impact to the patient beyond that which has already reported cannot be confirmed nor concluded.Should any additional relevant medical information be provided, this case could 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 revealed similar events for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the instructions for use documents for engage partial knee system revealed that periodic follow-up and x-rays are recommended to make comparisons with the immediate postoperative condition and identify implant displacement, loosening, etc.Excessive physical activity, and operated limb traumas may cause early failure of the arthroplasty through implant displacement, fracture and/or wear.If the case occurs, it is necessary to place the patient under supervision, evaluate the possible progression of the deterioration, and weigh the benefit of early revision has been identified as a postoperative care.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.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 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.H6: health effect - clinical code and health effect - impact code.
Additional Manufacturer Narrative
H3, h6, h7, h9: the device was not returned for evaluation; therefore, a device analysis could not be performed.The photographs were reviewed, and did not confirm any failure.The device shows signs of use.The clinical/medical investigation concluded that, per the complaint details, currently we are unable to rule out a procedural variance as a contributing factor to the reported event which does not represent a device malfunction.Based on the information provided, the surgeon conducted the surgical technique using another company¿s tibial cutting guide, this is considered off label per the engage instructions for use and standard treatment guides.Additionally, per the engage instructions for use, it is contraindicated for use of fixed tibial deformities (tibia vara).Based on the information provided, the revision was successful, however, the patient¿s outcome was reported as unknown.Therefore, the impact to the patient beyond that which has already reported cannot be confirmed nor concluded.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 in the postoperative care section that periodic follow-up and x-rays are recommended to make comparisons with the immediate postoperative condition and identify implant displacement, loosening, etc.Excessive physical activity, and operated limb traumas may cause early failure of the arthroplasty through implant displacement, fracture and/or wear.If the case occurs, it is necessary to place the patient under supervision, evaluate the possible progression of the deterioration, and weigh the benefit of early revision.Additionally, the warnings and precautions section revealed that the success of the operation depends on the compliance with the operative technique supplied, and the proper use of the instrumentation supplied and specially designed for that range of implants.The device has been validated for use with instruments by engage surgical, therefore it should only be used in combination with engage surgical instruments.Finally, the contraindications section revealed that unicompartmental replacement is contraindicated in patients who have a permanent valgus or varus deformity.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 surgical technique used or user/procedural variance and patient anatomy.Based on this investigation, the need for corrective action may be indicated.

• Brand Name: POROUS TIBIAL TRAY SIZE 2-LEFT 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: 14332542
• Report Number: 1020279-2022-02241
• Device Sequence Number: 6265535
• Product Code: NJD
• UDI-Device Identifier: 00885556873137
• UDI-Public: 885556873137
• 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,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: 1-10012-200
• Device Lot Number: 100053
• 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: 06/17/2022; 06/22/2023
• Initial Report FDA Received Date: 05/08/2022
• Supplement Report FDA Received Date: 06/21/2022; 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-LEFT MEDIAL-100184; TIBIAL ANCHOR STEM SIZE 1-2-100069; TIBIAL INSERT SIZE 2-LEFT MED 9MM-100201
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Female