MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRN II BCS BOX PREP GD SZ6-8; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	74012576
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: internal complaint reference: (b)(4).H3, h6: this complaint was opened by smith+nephew to document a patient complication related to a product problem with a smith+nephew device.The reported issue(s) relate to known inherent device and/or procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are submitting this report in accordance with applicable regulations.If additional investigative findings or information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Event or Problem Description
It was reported that, after a tka surgery performed on (b)(6) 2025, a post operative x-ray revealed that one of the screws at the hinge of one (1) jrn ii bcs box prep gd sz6-8 had become loose and slid out of place during the removal of the guide.As a result, the loose screw was inadvertently left inside the patient¿s knee.This adverse event was treated with a revision surgery on the same day to remove the screw.Current health status of the patient is unknown.
Event or Problem Description
It was reported that, after a tka surgery performed on (b)(6) 2025 for treatment of primary osteoarthritis, a post operative x-ray revealed that one of the screws at the hinge of one (1) jrn ii bcs box prep gd sz6-8 had become loose and slid out of place during the removal of the guide.As a result, the loose screw was inadvertently left inside the patient¿s knee.This adverse event was treated with a revision surgery on the same day to remove the screw.Current health status of the patient is unknown.
Additional Manufacturer Narrative
H11: h2: additional information on: b5.
Additional Manufacturer Narrative
Additional information: a2, a3, e4, h6, h10 and h11.H11: the device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, the provided electronic copy of x-ray imaging appears to support the complaint with a radio-dense/metallic object superolateral of lateral femoral condyle/femoral component which appears to be in the soft tissues.The surgical technique notes to apply hand pressure to manually engage pegs and states to remove the bcs box prep guide by lifting up on the outside casing to disengage the pegs and sliding anteriorly.The instructions for use notes to visually inspect for damage or wear and careful inspection and functional test of the device before use is the best method of determining the end of serviceable life for the medical device.A surgical technique/procedure variance and/or mechanical factors cannot be ruled out as potential contributing factors to the reported event as these documents include guidance for appropriate usage.The patient impact is determined to be the retained foreign body and subsequent same-day additional surgical procedure to remove it.Although the additional surgical procedure increased the risk of infection, no further complications have been reported; therefore, further patient impact is not anticipated.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 part number 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 care, maintenance, cleaning and sterilization of smith & nephew orthopedics devices revealed that visually inspecting for damage or wear, including components in their disassembled state prior to re-assembly as well as ensuring components are re-assembled securely is indicated.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 evidence to conclude that the product failed to meet any specifications at the time of manufacture.Based on this investigation, the need for corrective action is not 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.Internal complaint reference: case-(b)(4).

• Brand Name: JRN II BCS BOX PREP GD SZ6-8
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• 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 ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 23185804
• Report Number: 1020279-2025-01618
• Device Sequence Number: 9182555
• Product Code: JWH
• UDI-Device Identifier: 00885556001042
• UDI-Public: 885556001042
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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,Followup
• Report Date (Section B): 11/05/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 74012576
• Device Lot Number: 14EM22239
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2025
• Supplement Date Received by Manufacturer: 10/28/2025; 10/30/2025
• Initial Report FDA Received Date: 09/30/2025
• Supplement Report FDA Received Date: 10/28/2025; 11/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/29/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 69 YR
• Patient Sex: Female