MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II CR FEM OX NP RT SZ 3; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	74021153
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/18/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an unspecified surgical procedure due to stiffness.There is only information of the femoral component and tibial base component being involved.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history did not reveal additional complaints for the listed batches.The medical investigation concluded that, per the crfs, the patient underwent a r tka for oa but started developing increased stiffness by the 3-month check-up as evidenced by the study questionnaire.The reported ae#1 ¿pre-tka stiffness¿ was recorded as moderate severity, not serious, with a start date of (b)(6) 2018 (approx.5 months post r tka).Actions taken noted surgery/procedure with an outcome of not recovered/not resolved.It is unknown if the recorder was referring to the patient¿s actual pre-right tka stiffness as being unresolved post tka; however, the relationship to the study device was ¿possibly¿.Per crf documentation, the patient did not return for the 6-month check-up nor ¿follow-up with dr.Before leaving the hospital¿ following an unspecified (b)(6) 2019 surgery.Based on the limited information provided, the root cause of the reported ae#1 and the patient impact beyond the reported symptoms and unspecified surgery could not be determined.No further medical assessment can be rendered at this time.Without the actual device involved our investigation cannot proceed.If the device or new information is received in the future, the complaints can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: JRNY II CR FEM OX NP RT SZ 3
• 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: 9068748
• Report Number: 1020279-2019-03374
• Device Sequence Number: 16581735
• Product Code: JWH
• UDI-Device Identifier: 00885556422861
• UDI-Public: 00885556422861
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2019

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: 74021153
• Device Lot Number: 17KM06701A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/20/2019
• Supplement Date Received by Manufacturer: 11/22/2019
• Initial Report FDA Received Date: 09/16/2019
• Supplement Report FDA Received Date: 11/27/2019
• 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