MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY BCS PAT RESRF RD 32 MM STD; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	74024832
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/21/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a manipulation under anesthesia due to arthrofibrosis.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A clinical evaluation was conducted and no clinically relevant supporting documentation was provided; therefore, a thorough medical investigation could not be performed.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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 BCS PAT RESRF RD 32 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: 8868024
• Report Number: 1020279-2019-02962
• Device Sequence Number: 2753507
• Product Code: JWH
• UDI-Device Identifier: 03596010554536
• UDI-Public: 03596010554536
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K042515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,study,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2019

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: 74024832
• Device Lot Number: 18CM20423
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/13/2019
• Supplement Date Received by Manufacturer: 11/20/2019
• Initial Report FDA Received Date: 08/07/2019
• Supplement Report FDA Received Date: 11/22/2019
• 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
• Patient Age: 79 YR