MAUDE Adverse Event Report: SMITH & NEPHEW, INC. POROUS TIBIA BSEPLATE W/JRNY LOCK SZ4 LT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	71425324
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Joint Laxity (4526)
Date of Event	11/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after primary tka surgery had been performed on (b)(6) 2024, the patient experienced the femur to be loose.It was accompanied by pain and stiffness.This adverse event was solved by revision surgery on (b)(6) 2024, in which one (1) porous tibia baseplate w/jrny lock sz4 lt was explanted.Patient is recovering from surgery.No further complications were reported.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H3, h6: the associated tibial baseplate was returned and evaluated.The retrieved tibial baseplate was examined using macroscopic/microscopic and visual methods.Macroscopic/microscopic examination showed an appearance of bone substance adhered to the distal bone contacting surfaces.Visual examination showed scratches and wearing on the superior lock detail surfaces.No additional unexpected visual features noted.No evidence of deviation in processing or material was found for the retrieved item.Destructive testing was not performed during this examination.No definitive conclusions as to the cause of these issues can be determined.A review of the production orders for all the reported devices did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history revealed a similar event for the listed devices over the previous 12 months, but no similar events for the batches 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 knee systems revealed in the possible adverse effects section that decreased range of motion and looseness of components can result from trauma, improper implant selection, improper implant positioning, improper fixation, and/or migration of the components.Muscle and fibrous tissue laxity can also contribute to these conditions.Besides, this section states that temporary or permanent nerve damage can result in pain or numbness of the affected limb.A review of the risk management files 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 these products and event.At this time, we have no evidence to conclude that the products failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include abnormal motion over time, bone degeneration, size selected, lack of ingrowth, osteolysis and/or injury.Based on this investigation, the need for corrective action is not indicated.Should 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 SZ4 LT
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• 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: 20833367
• Report Number: 1020279-2024-02544
• Device Sequence Number: 19841720
• Product Code: MBH
• UDI-Device Identifier: 00885556733059
• UDI-Public: 885556733059
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K211221
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 01/06/2025

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: 71425324
• Device Lot Number: 24CM06029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2024
• Supplement Date Received by Manufacturer: 01/03/2025
• Initial Report FDA Received Date: 12/03/2024
• Supplement Report FDA Received Date: 01/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2024
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LGN CRHF XLP INS W/JRNY LCK 3-4:71425338,23AM12022; LGN POR CR HA FEM SZ 6 LT:71425206,22ETX0117A; POROUS ROUND PATELLA SZ 32MM:74025464,23KM19140A
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown