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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Arthralgia (2355); Deformity/ Disfigurement (2360)
Date of Event	11/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that, after a right unicompartmental knee arthroplasty had been performed on (b)(6) 2021, the patient experienced weight bearing pain at the joint line 5 months postoperatively.A substantial amount of residual varus in the long limb alignment was revealed by postoperative anteroposterior x-rays of the right tibia.A revision surgery was performed on (b)(6) 2021 to treat this adverse event.During this procedure, all components were explanted and replaced with a full tka construct.Intraoperatively, all implants were well fixed and with a good bone ingrowth if porous coated.The patient's outcome is unknown.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation.An x-ray demonstrated a substantial amount of residual varus in the long limb alignment, supporting the event.The pictures provided were reviewed and could not confirm the reported failure mode and adverse event.However, the clinical/medical investigation concluded that, the engage surgical ifu for the device, lists permanent valgus or varus deformity that requires correction for the knee to function satisfactorily post-op as a contraindication for partial knee replacement.Therefore, based on the information provided, we cannot rule out the patient¿s existing varus deformity or early bone remodeling as contributing factors to the patient¿s pain.The patient impact beyond the revision 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 based on the historical data revealed similar events for the listed batch, 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 pain has been identified as a adverse effect and complication.Also, the contraindications section establishes that unicompartmental replacement is contraindicated in patients who have a permanent valgus or varus deformity that requires correction for the knee to function satisfactorily post-op.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that a similar event was identified and determined that the primary root cause for revision surgeries 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 patient medical history or joint tightness.The contribution of the device to the reported incident could be corroborated as it was required a revision surgery to treat this event.Based on this investigation, the need for corrective action is not indicated.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
H3, h6: the device was not returned for evaluation.The pictures provided were reviewed and did not reveal any defects.However, the clinical/medical investigation concluded that, the engage surgical instructions for use for the device, lists permanent valgus or varus deformity that requires correction for the knee to function satisfactorily post-op as a contraindication for partial knee replacement.Therefore, based on the information provided, we cannot rule out the patient¿s existing varus deformity or early bone remodeling as contributing factors to the patient¿s pain.The patient impact beyond the revision 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 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 has been identified as a adverse effect and complication.Also, the contraindications section establishes that unicompartimental replacement is contraindicated in patients who have a permanent valgus or varus deformity that requires correction for the knee to function satisfactorily post-op.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.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: 14332483
• Report Number: 1020279-2022-02237
• Device Sequence Number: 5137809
• Product Code: NJD
• UDI-Device Identifier: 00885556873205
• UDI-Public: 885556873205
• 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: 2021
• 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): 06/27/2023

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: 1-10012-550
• Device Lot Number: 100061
• 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: 06/24/2022; 06/23/2023
• Initial Report FDA Received Date: 05/08/2022
• Supplement Report FDA Received Date: 06/27/2022; 06/27/2023
• 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 4-RIGHT MEDIAL-100011.; TIBIAL ANCHOR STEM SIZE 5-6-100074.; TIBIAL INSERT SIZE 5-RIGHT MED 10MM-100100.
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 83 KG