MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY BCS PAT RESRF RD 35 MM STD; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	74024835
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/24/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Manipulation under anesthetic - as a consequence of, knee gave way whist performing squats in the pool, causing significant pain.No specific component of the total knee system was assessed as to be the main complained device.
Additional Manufacturer Narrative
The associated complaint devices were not returned.The clinical/medical team concluded, all documents provided as of this date have been reviewed and considered.No relevant supporting clinical information has been provided to assist with a clinical investigation, and the patient's current condition is unknown.Therefore based on insufficient information, a thorough clinical assessment cannot be performed at this time.Should additional information be provided, the clinical/medical investigation can be re-evaluated at that time.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed parts revealed no prior complaints for the listed batches/failure mode.Without the actual device involved our investigation cannot proceed.If the device or new information is received in the future, the complaints can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: JRNY BCS PAT RESRF RD 35 MM STD
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8483565
• Report Number: 1020279-2019-01388
• Device Sequence Number: 1315108
• Product Code: JWH
• UDI-Device Identifier: 03596010554543
• UDI-Public: 03596010554543
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K042515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2019

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 Expiration Date: 01/26/2025
• Device Catalogue Number: 74024835
• Device Lot Number: 15AM20094
• Initial Date Received by Manufacturer: 03/11/2019
• Supplement Date Received by Manufacturer: 03/11/2019
• Initial Report FDA Received Date: 04/04/2019
• Supplement Report FDA Received Date: 10/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention