MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY TIBIA BASE NP LT SZ 7; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	74022227
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/19/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a manipulation under anesthesia due to the knee is barely at 60 degree of flexion and the patient certainly lacks the last 15 or so degrees of extension.Intensifying physiotherapy and rehabilitation is failing to make any significant or meaningful progress.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A clinical evaluation was conducted and based on a review of clinical documentation provided the physiotherapy has failed to correct the issue of the limited flexion.It was also reported the patient received prophylactic antibiotics as well as anticoagulant therapy.The root cause of the limited amount of flexion may be contributed to arthrofibrosis from multiple knee procedures.It is unknown if the patient followed the physical therapy treatment plan postoperatively and consistently.The patient impact beyond the limited range of motion and need for extended hospital stay is inconclusive.It was reported that the mua resolved the immobility issues and the dvt was resolved with medication.No further clinical assessment is warranted at this time.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: JOURNEY TIBIA BASE NP LT SZ 7
• 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: 8661090
• Report Number: 1020279-2019-02098
• Device Sequence Number: 2286102
• Product Code: JWH
• UDI-Device Identifier: 03596010554406
• UDI-Public: 03596010554406
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2019

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: 74022227
• Device Lot Number: 17DM06296
• Initial Date Received by Manufacturer: 05/06/2019
• Supplement Date Received by Manufacturer: 05/06/2019
• Initial Report FDA Received Date: 05/31/2019
• Supplement Report FDA Received Date: 10/23/2019
• 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