MAUDE Adverse Event Report: SMITH & NEPHEW, INC. POROUS FEMORAL COMP SIZE 4-LEFT MEDIAL; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	1-10003-410
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Arthralgia (2355)
Date of Event	10/04/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after unicompartmental knee replacement surgery had been performed on (b)(6) 2021, the patient experienced knee pain for over a year since surgery.This uni was a pressfit engage partial knee.This adverse event was treated by a revision surgery on (b)(6) 2022.Current health status of patient its unknown.Upon trying to remove the tibial anchor, the anchor broke, which increased the explantation time.The procedure was completed using a competitor device.Surgery was completed with a non-significant delay.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
D4: lot number updated to 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, per the complaint details, a revision/conversion to a tka was performed approximately 15.5 months post-uni knee due to persistent pain over the year since implantation.Reportedly, although the tibial anchor broke during explantation, the procedure was completed using a competitor device with a non-significant delay.The provided images of the explanted component does not provide insight into the root cause of the reported event.As of the date of this medical investigation, the requested clinical information has not been received; therefore, no clinical factors could be concluded to have contributed to the reported event(s).The patient impact beyond the reported revision/conversion to competitor tka due to pain, the intra-operative complication/anchor breakage and subsequent surgical delay (0-30 min) could not be determined.No further medical assessment can be rendered at this time.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 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 reveals that pain can result from improper positioning, loosening or wear of the components.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 no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors that could contribute to the reported event include traumatic injury, joint tightness, patient condition or postoperative care.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.
Event or Problem Description
It was reported that, after unicompartimental knee replacement surgery had been performed on(b)(6) 2021, the patient experienced knee pain for over a year since surgery.This uni was a pressfit engage partial knee.This adverse event was treated by a revision surgery on (b)(6) 2022.Current health status of patient its unknown.Upon trying to remove the tibial anchor, the anchor broke, which increased the explantation time.A medacta total knee was used for the total knee conversion.
Additional Manufacturer Narrative
The devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, per the complaint details, a revision/conversion to a total knee arthroplasty was performed approximately 15.5 months post-uni knee due to persistent pain over the year since implantation.Reportedly, although the tibial anchor broke during explantation, the procedure was completed using a competitor device with a non-significant delay.The provided images of the explanted component does not provide insight into the root cause of the reported event.As of the date of this medical investigation, the requested clinical information has not been received; therefore, no clinical factors could be concluded to have contributed to the reported event(s).The patient impact beyond the reported revision/conversion to competitor total knee arthroplasty due to pain, the intra-operative complication/anchor breakage and subsequent surgical delay (0-30 min) could not be determined.No further medical assessment can be rendered 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 reveals that pain can 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 product specifications at the time of manufacture.Factors that could contribute to the reported event include traumatic injury, joint tightness or patient condition.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action may be indicated.

• Brand Name: POROUS FEMORAL COMP SIZE 4-LEFT MEDIAL
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-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: 15674642
• Report Number: 1020279-2022-04571
• Device Sequence Number: 6462371
• Product Code: HSX
• UDI-Device Identifier: 00885556872994
• UDI-Public: 885556872994
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,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: 01/05/2026
• Device Catalogue Number: 1-10003-410
• Device Lot Number: 100185
• 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: 10/04/2022
• Supplement Date Received by Manufacturer: 11/15/2022; 11/17/2022; 11/25/2022; 06/23/2023
• Initial Report FDA Received Date: 10/26/2022
• Supplement Report FDA Received Date: 11/15/2022; 11/18/2022; 12/01/2022; 06/26/2023
• 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: A
• 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: PN: 1-10013-409 / LOT: 100124; PN: 1-10011-200 / LOT: 100070; PN: 1-10012-400 / LOT: 100055
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown