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

Model Number	74029237
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/26/2016
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
The associated complaint devices were not returned.A clinical analysis indicated 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 manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the listed parts did not reveal additional complaints for the listed batches.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.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: 7875759
• Report Number: 1020279-2018-01827
• Device Sequence Number: 16659478
• 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
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/22/2023

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 Model Number: 74029237
• Device Catalogue Number: 74029237
• Device Lot Number: 15DM01183
• Initial Date Received by Manufacturer: 06/19/2018
• Supplement Date Received by Manufacturer: 06/19/2018; 05/03/2023; 11/21/2023
• Initial Report FDA Received Date: 09/14/2018
• Supplement Report FDA Received Date: 05/07/2019; 05/31/2023; 11/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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; Required Intervention
• Patient Age: 49 YR
• Patient Sex: Female