MAUDE Adverse Event Report: SMITH & NEPHEW, INC. POROUS FEMORAL COMP SIZE 4-RIGHT MEDIAL; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, UNICOMPARTMENTAL/UNICONDYLAR,

Catalog Number	1-10003-400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abscess (1690); Pain (1994); Arthralgia (2355)
Date of Event	11/08/2021
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 pain and developed a suture abscess 6-7 weeks postoperatively.A revision surgery with an irrigation and debridement (i&d) was performed on (b)(6) 2021 to treat this adverse event.As part of the intervention performed, the femoral component and the tibial insert were removed with standard instrumentation and replaced with new cemented implants.The patient's outcome is unknown.
Additional Manufacturer Narrative
The device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, he patient¿s history of multiple knee surgeries cannot be ruled out as a contributing factor to the reported pain.Based on the information provided, startup pain is common with cementless partial knee replacements that tends to resolve itself within the first year of implantation.Without the supporting lab/pathology results, imaging, and/or the analysis of the explanted components, the root cause of the suture abscess cannot be confirmed.The abscess is highly likely of an exogenous nature and there is no evidence that our product contributed to the infection.It should be noted that surgeon was unclear on how well-fixed the femoral component was before removing.The patient impact beyond that which has already been reported cannot be determined.No further clinical 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 risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A review of the instructions for use for this device reveals that early or late infection which may require removal of the implant followed by arthrodesis or 2-stage reimplantation in the adverse effects and complications section.Also pain resulting from improper positioning, loosening or wear of the components.A review of the sterilization records revealed the batch was sterilized within normal parameters.A historical review concluded that a similar event was identified due to a spike in the complaints where a revision surgery was performed, 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 are not limited to contamination, patient reaction, and post-operative healing issue.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
The device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, the patient¿s history of multiple knee surgeries cannot be ruled out as a contributing factor to the reported pain.Based on the information provided, startup pain is common with cementless partial knee replacements that tends to resolve itself within the first year of implantation.Without the supporting lab/pathology results, imaging, and/or the analysis of the explanted components, the root cause of the suture abscess cannot be confirmed.The abscess is highly likely of an exogenous nature and there is no evidence that our product contributed to the infection.It should be noted that surgeon was unclear on how well-fixed the femoral component was before removing.The patient impact beyond that which has already been reported cannot be determined.No further clinical 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 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.A review of the instructions for use documents for engage partial knee system revealed that early or late infection which may require removal of the implant followed by arthrodesis or 2-stage reimplantation in the adverse effects and complications section.Also pain resulting from improper positioning, loosening or wear of the components.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.A review of the sterilization records revealed the batch was sterilized within normal parameters.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 loss of sterility during procedure, post-operative healing issue, injury, patient condition and/or medical history.Based on this investigation, the need for corrective action may be indicated.

• Brand Name: POROUS FEMORAL COMP SIZE 4-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: 14335942
• Report Number: 1020279-2022-02232
• Device Sequence Number: 17722841
• Product Code: NJD
• UDI-Device Identifier: 00885556872987
• UDI-Public: 885556872987
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/12/2023

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: 01/05/2026
• Device Catalogue Number: 1-10003-400
• Device Lot Number: 100179
• 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: 07/08/2022; 06/07/2023
• Initial Report FDA Received Date: 05/09/2022
• Supplement Report FDA Received Date: 07/11/2022; 06/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2021
• 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 3-RIGHT MEDIAL-100066.; TIBIAL ANCHOR STEM SIZE 3-4-100075.
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 40 YR
• Patient Sex: Female