MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN HK FEM ASSEMBLY SZ 7 RT; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	71421367
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Anemia (1706); Bone Fracture(s) (1870)
Date of Event	09/22/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after the implantation of a right legion hk system on (b)(6) 2020, the patient felt a crack while changing pants on (b)(6) 2020.An undisplaced peri-prosthetic fracture on the medial condyle was diagnosed via ct and x-rays.Physical therapy was suspended and the patient was placed on a splint; however, as the fracture was displacing, a revision surgery was prescribed.The femoral assembly was replaced and three wire cerclages were installed on (b)(6) 2020 to address this event.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
Results of investigation: the device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, the provided sub-optimal x-ray image appears to show a non-displaced cleaved, distal femoral fracture just proximal of the medial condyle.Post second revision images (dated on (b)(6) 2020) appear to show implantation of a long, forked-stem femoral component along with three cerclage wires to reduce the distal femoral fracture but root cause of the periprosthetic fracture is not clear.The preliminary dismissal letter (dated on (b)(6) 2020) indicated patient was to mobilize (post second revision) according to the total knee arthroplasty scheme with a maximum load imitation of 15-20 kg for six weeks with locked orthosis and orders for x-rays and computed tomography prior to starting the rehab procedure.All documents and images provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical/medical investigation.In conclusion, based on the documentation provided, the event was likely multi-factorial given the first revision hinge knee procedure itself (performed approximately 5 weeks prior to onset of knee ¿stinging¿/pain) and the patient metabolic disorder/comorbidities.Periprosthetic fractures are a known possible, occurrence status post total knee arthroplasty; however, risks are believed to increase post-revision procedures.Based on the limited documentation provided, a component nonperformance is not supported.Cannot rule out weight bearing compliance as a factor.The patient impact included the acute onset of fracture with symptoms while at rehab, immobilizer brace, with a subsequent progressive distal femoral fracture displacement, hinge knee revision with reduction/osteosynthesis and the blood transfusion due to anemia.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 that femur fractures have been identified in possible adverse effects.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 specifications at the time of manufacture.Factors that could contribute to the reported event include patient bone quality, post-operative patient condition and/or surgical technique.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.We consider this investigation closed.

• Brand Name: LGN HK FEM ASSEMBLY SZ 7 RT
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, 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: 18123195
• Report Number: 1020279-2023-02224
• Device Sequence Number: 7512779
• Product Code: KRO
• UDI-Device Identifier: 00885556414927
• UDI-Public: 00885556414927
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K081111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2024

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 Expiration Date: 05/21/2026
• Device Catalogue Number: 71421367
• Device Lot Number: 19DM28248
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2023
• Supplement Date Received by Manufacturer: 12/28/2023
• Initial Report FDA Received Date: 11/13/2023
• Supplement Report FDA Received Date: 01/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PN: 71421386 / LOT: 19HTM0034A; PN: 71422166 / LOT: 14DAP7253A; PN: 71423366 / LOT: 14BM08089R; PN: 71424225 / LOT: 19GSM0094
• Patient Age: 58 YR
• Patient Sex: Male