MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY UNI TIBIAL BASE LM/RL SZ 3; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	71422423
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/20/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient was complaining of persistent pain and swelling, longer than usual.He took an x-rays on (b)(6) 2019 showing a suspicious fracture.He denied any fall injury.Clinically, there was persistent effusion.Knee aspiration yielded 30ml straw coloured joint fluid was sent for culture.Smear was negative.Urgent ct confirmed a medial tibial plateau fracture.Dr.(b)(6)'s working diagnosis is medial tibial plateau fracture, post-ukr.Need to exclude pathological fracture/ stress fracture.Blood test for esr/ crp are pending.
Event or Problem Description
It was reported that a patient was complaining of persistent pain and swelling, longer than usual.He took an x-rays on (b)(6) 2019 showing a suspicious fracture.He denied any fall injury.Clinically, there was persistent effusion.Knee aspiration yielded 30ml straw coloured joint fluid was sent for culture.Smear was negative.Urgent ct confirmed a medial tibial plateau fracture.A revision was performed on january 24th, due to the tibial baseplate was broke, and the femoral component and insert were also removed.
Additional Manufacturer Narrative
Expiration date, catalog #, lot #, udi #, concomitant medical products,pma/510k,if follow-up, what type and device manufacture date is additional information that was received for this case.
Additional Manufacturer Narrative
The associated journey uni tibial baseplate, journey uni insert and journey uni oxinium femoral component were not made available for evaluation.Therefore a product evaluation could not be performed.However, device details were provided.Thus, a review of device history record and complaint history were performed.The review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A review of complaint history on the listed parts revealed no prior complaints for the listed batch with the same failure mode.This investigation could not determine a specific cause of failure.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Without the return of the actual product involved, our investigation of this report is inconclusive.Our clinical evaluation noted that based on the provided x-ray images, the bone quality cannot be determined and the root cause of the tibial plateau fracture along with the reported broken tibial baseplate cannot be concluded.However, overload fatigue with a slightly large tibial component could be possible contributing factors.The patient impact beyond the reported symptoms and possible revision procedure cannot be determined.No further investigation is warranted for this complaint; however, smith and nephew will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, this complaint will be reopened and reevaluated.

• Brand Name: JRNY UNI TIBIAL BASE LM/RL SZ 3
• 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: 8334117
• Report Number: 1020279-2019-00548
• Device Sequence Number: 13828088
• Product Code: HSX
• UDI-Device Identifier: 00885556087947
• UDI-Public: 00885556087947
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K102069
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/13/2019

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: 71422423
• Device Lot Number: 17EM06193
• Initial Date Received by Manufacturer: 01/20/2019
• Supplement Date Received by Manufacturer: 02/05/2019; 02/05/2019
• Initial Report FDA Received Date: 02/12/2019
• Supplement Report FDA Received Date: 02/21/2019; 05/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 71422251/18BM08427; 71422342/16JM02089
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention