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	12/11/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient had right knee pain and stiffness and it was resolved with a manipulation under anesthesia.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A clinical evaluation was conducted and it was reported that patient had right knee pain and stiffness and it was resolved with a manipulation under anesthesia.There were no x-rays or intraoperative records provided.The root cause of the pain and stiffness is unknown other than the possibility of inability of the patient to participate in physical therapy or rehab post op.This is usually related to rehabilitation and scarring.There is a history of tka two years prior to pain and stiffness.The patient impact beyond the mua procedure is inconclusive.It was noted that this issue was resolved.No further clinical assessment is needed at this time.(arthrofibrosis complaint) immobility of the joint due to the formation of bone, cartilaginous or fibrous tissues around the joints.Fibrosis (arthrofibrosis complaint) the formation of fibrous tissue.Additional surgery (arthrofibrosis complaint) surgical intervention that was not planned and needed to be performed in addition to other interventions including surgical ones.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: 8845186
• Report Number: 1020279-2019-02873
• Device Sequence Number: 11407058
• Product Code: JWH
• UDI-Device Identifier: 03596010554536
• UDI-Public: 03596010554536
• Combination Product (Y/N): N
• 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): 11/26/2019

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: 07/13/2026
• Device Catalogue Number: 74024832
• Device Lot Number: 16GM10471
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/02/2019
• Supplement Date Received by Manufacturer: 10/30/2019
• Initial Report FDA Received Date: 07/31/2019
• Supplement Report FDA Received Date: 11/26/2019
• 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