MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS CNSTRD ART ISRT 3-4 RT 18M; PRSTHSS, KNEE, PTLLFMRTBIAL, SM-CNSTRND, CMNTD, POLYMER/METAL/POLYMER

Catalog Number	74029237
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Injury (2348); Joint Dislocation (2374)
Date of Event	07/16/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient had dislocation and manipulation under anesthesia was needed to treat it.
Additional Manufacturer Narrative
H10: additional information : the devices were not returned for evaluation.The clinical/medical investigation concluded that, the patient's history and long-term continued use of high dose oxycodone, complex medical comorbid conditions including peripheral neuropathy, multiple sclerosis, generalized weaknesses, multiple falls and reported non-compliance to medical regimen cannot be excluded as factors contributing to the dislocations and reported revisions.The source of the joint effusions, reported pale yellow, gray-tan hard articular bone and cartilage and rubbery yellow tan synovial tissue and fibrocartilage of the bone and tissue samples cannot be confirmed.The patient impact beyond the reported dislocations, revisions, and continued pain cannot be determined.Without the return of the explanted devices the exact root cause of the reported prosthetic fracture cannot be concluded.A review of the production orders 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 for almost 7 years 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 system revealed dislocation as a result from trauma, improper implant selection, improper implant positioning, improper fixation, and/or migration of the components.Muscle and fibrous tissue laxity can also contribute to these conditions, this has been identified as possible adverse effects.A review of the risk management files 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 these products and event.At this time, we have no reason to suspect that the products failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include traumatic injury, patient anatomy, postoperative care or abnormal loading of limb.Based on this investigation, the need for corrective action is not indicated.Should the devices 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 CNSTRD ART ISRT 3-4 RT 18M
• Common Device Name: PRSTHSS, KNEE, PTLLFMRTBIAL, SM-CNSTRND, CMNTD, POLYMER/METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: sarah freestone ; 1450 brooks road; memphis, TN 38116
• MDR Report Key: 7875757
• Report Number: 1020279-2017-01826
• Device Sequence Number: 16656642
• Product Code: JWH
• UDI-Device Identifier: 00885556174715
• UDI-Public: 00885556174715
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K140555
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2023

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: 03/29/2025
• Device Catalogue Number: 74029237
• Device Lot Number: 15EM01183
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/19/2018
• Supplement Date Received by Manufacturer: 11/21/2023
• Initial Report FDA Received Date: 09/14/2018
• Supplement Report FDA Received Date: 12/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2015
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 74013480 - 10KNX0001; 74022115 - 14LM09879; 74022214 - 14EM21851; 74024832 - 13JM04188; 74013480 - 10KNX0001; 74022115 - 14LM09879; 74022214 - 14EM21851; 74024832 - 13JM04188
• Outcome Attributed to Adverse Event: Hospitalization; Congenital Anomaly; Required Intervention
• Patient Age: 49 YR
• Patient Sex: Female