MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS FEM COCR LT SZ 4; PROST, KNEE, PATFEMTIB, SEMI-CNSTRND, CMNTD, POL/MET/POL

Model Number	74024924
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	08/29/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during a tka, the impactor was inadvertently placed upside down on the jrny ii bcs femoral cocr lt sz 4.The problem was noticed once the implant was placed on the femur with cement, and the impactor did not dislodge.Surgeon attempted to dislodge it with a mallet, which then caused a fracture of the lateral condyle.The fracture was repaired with three (3) screws and remainder of procedure completed.The same impactor was used and surgery was prolonged for 15-20 min.Fracture caused patient prolonged recovery with only partial weight bearing, including unexpected rehab hospital care.
Additional Manufacturer Narrative
Initial mdr report.Internal reference: (b)(4).
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that based on the documentation provided, a user/procedural error contributed to the reported event.No clinical factors have been identified as a potential root cause.The patient impact included the reported bone fracture with subsequent 3-screw reduction, surgical delay, ¿prolonged recovery with only partial weight bearing, including unexpected rehab hospital care, and is still ongoing¿.Further patient impact 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 knee systems revealed in indications, contraindications, and adverse effects that the preoperative planning and meticulous surgical technique are essential to achieve optimum results.Considerations of component placement are critical to minimize a variety of postoperative complications.Warnings and precaution section states that during curing of cement, care should be taken to prevent movement of the implant 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 surgical technique used or user/procedural variance.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: JRNY II BCS FEM COCR LT SZ 4
• Common Device Name: PROST, KNEE, PATFEMTIB, SEMI-CNSTRND, CMNTD, POL/MET/POL
• 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: 15505394
• Report Number: 1020279-2022-04215
• Device Sequence Number: 5224553
• Product Code: JWH
• UDI-Device Identifier: 00885556611425
• UDI-Public: 00885556611425
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2022

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 Model Number: 74024924
• Device Catalogue Number: 74024924
• Device Lot Number: A1902993
• 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: 08/29/2022
• Supplement Date Received by Manufacturer: 11/10/2022
• Initial Report FDA Received Date: 09/29/2022
• Supplement Report FDA Received Date: 11/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/08/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 76 YR
• Patient Sex: Female