MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY BCS II FEMORAL OXIN RT SZ 4; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	74022114
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/31/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that study no.: (b)(6) was revised due to excessive adhesion and lack of joint movement;.
Event or Problem Description
It was reported that the patient presented excessive ankylosis of right knee resulting in severe limited range of motion and development of scar tissue resulting in a closed manipulation.First mua (b)(6) 2016.Second procedure for this ae was an arthrosopic removal of lysis adhesions and a second mua on 23-sep-2016.As ae did not resolve, a full revision, except for patellar component was necessary.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A clinical evaluation was conducted and no relevant clinical medical information was provided to conduct a thorough medical assessment.Should any additional clinical information be provided this complaint will be re-assessed.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 II FEMORAL OXIN RT SZ 4
• 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: 8560799
• Report Number: 1020279-2019-01700
• Device Sequence Number: 1586481
• Product Code: JWH
• UDI-Device Identifier: 00885556169865
• UDI-Public: 00885556169865
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/30/2019

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: 04/18/2025
• Device Catalogue Number: 74022114
• Device Lot Number: 15DM14161
• Initial Date Received by Manufacturer: 04/08/2019
• Supplement Date Received by Manufacturer: 08/06/2019; 08/06/2019
• Initial Report FDA Received Date: 04/29/2019
• Supplement Report FDA Received Date: 08/28/2019; 10/30/2019
• 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