MAUDE Adverse Event Report: SMITH & NEPHEW, INC. POROUS TIBIA BSEPLATE W/JRNY LOCK SZ6 RT; PROSTH, KNEE, PATELLO/FEM, SEMI-CONSTR, UNCEMENT, POROUS, COAT, POLY/METAL/POLY

Catalog Number	71425306
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Pain (1994); Inadequate Osseointegration (2646)
Date of Event	10/05/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal reference: (b)(4).
Event or Problem Description
It was reported that, after tka was performed on an unknown date, the patient experienced ongoing pain.X-rays confirmed a gap on the lateral side of the tibia.The tibia was not fully seated and no bony ingrowth was observed.This adverse event was treated with a revision surgery on (b)(6) 2022, in which the femur, tibia, and insert were exchanged.As there was no issue with the patella, it was left in the patient.Patient's current health status 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, per the complaint details, the primary tibia was not fully seated and a revision (of femoral, tibial and insert¿patella retained) was performed due to ongoing pain with x-ray confirmation of lateral sided tibial gap without bony ingrowth after an unknown duration in-vivo.As of the date of this medical investigation, the supporting clinical documentation has not been provided; therefore, definitive contributing clinical factors could not be concluded.With the limited information provided, the patient impact beyond the reported pain, lack of bony ingrowth and subsequent revision cannot 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 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 instructions for use documents for porous knee system revealed in warnings that the patient should be warned and made aware of possible adverse events.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 excessive pressure on the joint, injury, healing issues and/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 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.

• Brand Name: POROUS TIBIA BSEPLATE W/JRNY LOCK SZ6 RT
• Common Device Name: PROSTH, KNEE, PATELLO/FEM, SEMI-CONSTR, UNCEMENT, POROUS, COAT, POLY/METAL/POLY
• 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: 15705366
• Report Number: 1020279-2022-04614
• Device Sequence Number: 6490125
• Product Code: MBH
• UDI-Device Identifier: 00885556732991
• UDI-Public: 885556732991
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K211221
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2022

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: 71425306
• Device Lot Number: 21LM14622
• 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: 10/05/2022
• Supplement Date Received by Manufacturer: 11/24/2022
• Initial Report FDA Received Date: 10/31/2022
• Supplement Report FDA Received Date: 11/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2021
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 71423256 LGN POROUS CR FEM SZ 6R.; 71425347 LGN CRHF XLPE INS W/JRNY LCK SZ 5-6 10MM.
• Patient Sex: Unknown