MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKNOWN CEMENTLESS PARTIAL KNEE IMPL; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arthralgia (2355); Inadequate Osseointegration (2646)

Event Type  Injury  

Event Description

It was reported that, after a uka had been performed on an unspecified date with an engage partial knee system, the patient experienced pain.A revision surgery was conducted to address the adverse event.Current health status is unknown.

Manufacturer Narrative

Complaint reference number: (b)(4).

Manufacturer Narrative

Section h3, h6: the device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, per case details, after a unicompartmental knee arthroplasty surgery was performed, the patient reportedly underwent revision of the engage partial knee system due to pain.As of the date of this medical investigation, the requested clinical documentation has not been provided; therefore, there were no clinical factors found which would have definitively contributed to the event.The patient impact beyond the reported pain with a subsequent revision cannot be determined and the patient¿s current health status is unknown.Therefore, no further clinical/medical assessment can be rendered.Device specific identifiers were not provided.Therefore, an evaluation of the manufacturing records and complaint history review could not be performed.A review of the instructions for use documents for engage partial knee system revealed that pain has been identified in the adverse effects and complications as a result 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.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 or patient condition.Based on this investigation, the need for corrective action may be indicated.

Manufacturer Narrative

B5 event description.

Event Description

It was reported that, after a right uka had been performed on (b)(6) 2021 with an engage partial knee system, the patient started to experience increased pain throughout physical therapy.Testing produced findings consistent with a broken cervical screw.Therefore, a revision surgery was conducted in 2023 to address this adverse event.Current health status of the plaintiff is unknown.

Manufacturer Narrative

H10: additional information in a1, a2, a3, a4, b7, d1, d2, d4, d6, g4.H11: corrected information in h6 (health effect - clinical code and health effect - impact code).

Manufacturer Narrative

H3, h6: the device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, based on the bone scan report, implant loosening or failure to achieve bony integration most likely caused the patient¿s pain; however, a definitive clinical root cause of lack of integration or loosening cannot be concluded.It is unknown how the alleged ¿broken cervical screw¿ is related to the partial knee system and subsequent bilateral revision/conversion to total knee arthroplasty.The patient impact includes the reported increased pain post-partial knee replacements (left side greater than right), medication, physical-therapy and the bilateral revisions/conversations to total knee arthroplasty within 1-2 years of implantation, as well as anticipated post-surgical restorative phases.The current patient status remains unknown and further patient impact cannot be determined.A review of the production order 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 a similar event 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 in the adverse effects and complications as a result 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.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include implant loosening, failure to achieve bony integration, traumatic injury, joint tightness or patient condition.Based on this investigation, the need for corrective action may be 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.

• Brand Name: UNKNOWN CEMENTLESS PARTIAL KNEE IMPL
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• 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: 16994421
• MDR Text Key: 315862439
• Report Number: 1020279-2023-01126
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190439
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/12/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/03/2023
• Initial Date FDA Received: 05/24/2023
• Supplement Dates Manufacturer Received: 06/22/2023; 06/22/2023; 02/26/2024; 03/08/2024
• Supplement Dates FDA Received: 06/26/2023; 01/24/2024; 02/28/2024; 03/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1670-2023
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 96 KG