MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY II UNI TIBIA BASEPLATE SIZE 2 RM/LL; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	71935200
Date of Event	08/28/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a past periprosthetic tibia fracture occurred with calus formation around the tibia and without loosening.A revision surgery will not be performed but two crutches will be used to unload the operated limb.
Additional Manufacturer Narrative
Results of investigation: it was reported that a past periprosthetic tibia fracture occurred without loosening.The associated genesis ii ps high flexion insert, genesis ii cemented tibial base plate and legion ps femoral component, used in treatment, were not returned.Thus, no product analysis could be performed.A complaint history review found related failures, but none similar; this failure mode will be monitored for future complaints for any necessary corrective actions.Our investigation including a review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A relationship, if any, between the devices and the reported incident could not be corroborated.A clinical analysis noted that 6 provided x-rays confirm the report of a tibial fracture on the 3 month-post-op ap image.The implants remain in-situ therefore, the root cause of the reported peri-prosthetic tibia fracture cannot be determined but tibial weakening of the medial condyle cannot be ruled out as probable cause.It was reported that since callus formation has enveloped and no apparent loosening a revision will not be performed at this time.The patient has been reported as recovering with the use of crutches.A review of instructions for use revealed the alleged failure is previously identified in the potential adverse events.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual products involved, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as needed.Should additional information be received, this complaint will be reopened and reevaluated.We consider this investigation closed.
Event or Problem Description
It was reported that a past periprosthetic tibia fracture occurred with callus formation around the tibia and without loosening.A revision surgery will not be performed but two crutches were provided to the patient to unload the operated limb.Up to the (b)(6) 2019 the patient did not report any complaint or problem, but a periprostetic fracture was identified on the x-ray taken same date (aug 28, 2019), during the three months visit.It was observed that the mentioned fracture was nearly cured.Patient did not complaint of any pain or walking problems that time.It was informed by the patient that early during postoperative period, she experienced symptoms of pain and a edema around the knee, but no history of injury.Symptoms were resolved with heparin and anti-edema drugs a few days after patient went to the er on 8 july 2019.

• Brand Name: JOURNEY II UNI TIBIA BASEPLATE SIZE 2 RM/LL
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9164268
• Report Number: 1020279-2019-03581
• Device Sequence Number: 19362898
• Product Code: HSX
• UDI-Device Identifier: 00885556578797
• UDI-Public: 00885556578797
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K152315
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2020

1 Device 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: 71935200
• Device Catalogue Number: 71935200
• Device Lot Number: 18LAP0093B
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/11/2019
• Supplement Date Received by Manufacturer: 09/11/2019
• Initial Report FDA Received Date: 10/07/2019
• Supplement Report FDA Received Date: 02/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No