MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ENGAGE POROUS FEMORAL SZ 5-LT MED; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	1-10003-510
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Arthralgia (2355)
Date of Event	10/20/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after a uka surgery had been performed on an unspecified date, the patient complained of chronic pain.A revision surgery was performed on the (b)(6)2022 to treat this adverse event.The patient received a tka system in exchange.
Additional Manufacturer Narrative
B3 (date of event), b5 (event description), d6a (date of implantat ion).
Event or Problem Description
It was reported that, after a uka surgery had been performed on the (b)(6) 2021, the patient complained of chronic pain.A revision surgery was performed on the (b)(6) 2022 to treat this adverse event.The patient received a tka system in exchange.No further information is available at the moment.
Additional Manufacturer Narrative
H3, h6: the devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that per complaint details, a revision/conversion to total knee arthroplasty surgery was performed due to patient complaints of chronic pain.An electronic photo of a left unicompartmental knee arthroplasty charstiks sheet (dated (b)(6) 2021) and open surgical wound imaging (dated 10/20) were provided, which would likely indicate revision to be approximately 21 months post implantation; however, the photos do not provide insight into the clinical root cause of the reported event.Of note, the symptom onset date is unknown, and although the wound image date does not correlate with the reported occurrence date of 11/20/2022, this is believed to be only a typographical error in occurrence date (but no clarification has been received to date).Surgical details and if the components had bony integration or were loosened is unknown.The patient impact beyond the reported chronic pain and revision/conversion to total knee arthroplasty could not be determined.No further medical assessment could 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 revealed that pain has been identified in adverse effects and complications.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 products failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include traumatic injury, joint tightness, patient condition or postoperative care.Based on this investigation, the need for corrective action may be indicated.

• Brand Name: ENGAGE POROUS FEMORAL SZ 5-LT MED
• 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: 16554464
• Report Number: 1020279-2023-00556
• Device Sequence Number: 17415460
• Product Code: HSX
• UDI-Device Identifier: 00885556873014
• UDI-Public: 885556873014
• 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
• Report Date (Section B): 05/30/2023

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 Catalogue Number: 1-10003-510
• Device Lot Number: 100030
• 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: 11/20/2022
• Supplement Date Received by Manufacturer: 11/20/2022; 05/18/2023
• Initial Report FDA Received Date: 03/16/2023
• Supplement Report FDA Received Date: 04/17/2023; 05/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 1-10011-300/100071.; 1-10012-500 /100045.; 1-10013-509/100130.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown