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	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/05/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had difficulty to walk, right knee ankylosis and synovitis post-operative.The event was resolved performing an unspecified surgical procedure.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A clinical evaluation was conducted and it was communicated that the patient "failed to maintain rom after (right) tkr leading to this event".Per the crfs provided, 6 weeks post primary, the patient required an open synovectomy, irrigation and debridement and an mua for pain, decreased rom and synovitis.The events were documented as resolved as of 10/05/2017; therefore, no further patient impact is anticipated.No further medical assessment is warranted at this time.A review of complaint history on the listed parts revealed no prior complaints for the listed batches with the same failure mode.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.

• 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: 8897971
• Report Number: 1020279-2019-03067
• Device Sequence Number: 19208647
• Product Code: JWH
• UDI-Device Identifier: 03596010554543
• UDI-Public: 03596010554543
• Combination Product (Y/N): N
• PMA/510(K) Number: K042515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2019

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: 74024835
• Device Lot Number: 17FM04554
• Initial Date Received by Manufacturer: 07/16/2019
• Supplement Date Received by Manufacturer: 12/06/2019
• Initial Report FDA Received Date: 08/15/2019
• Supplement Report FDA Received Date: 12/10/2019
• 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