MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY BCS II FEMORAL OXIN LT SZ 7; PRSTHSS,KNEEL,SEMI-CONSTRNED,CMNTD,POLYMER/METAL/POLYMER

Catalog Number	74022127
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	07/07/2014
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a surgical intervention was performed due to a subluxed dislocated left patella.
Additional Manufacturer Narrative
The associated complaint devices were not returned due to devices are still implanted.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 on the listed part revealed no prior complaints for the listed batch with the same failure mode.A clinical analysis indicates that patient subluxed, dislocated patella status post left tka.Patient complained of chronically dislocated left patella; has also had severe falls and previous vmo repair after fall.Patient has failed attempts at conservative management.Study documented as severe; possibly related to the study device and procedure; and documented as resolved with residual effects.No radiological imaging or operative reports were provided for inclusion in a medical investigation.No further clinical assessment is warranted.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 II FEMORAL OXIN LT SZ 7
• Common Device Name: PRSTHSS,KNEEL,SEMI-CONSTRNED,CMNTD,POLYMER/METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7137535
• Report Number: 1020279-2017-01316
• Device Sequence Number: 19100041
• Product Code: JWH
• UDI-Device Identifier: 00885556170519
• UDI-Public: 00885556170519
• 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: 2012
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/11/2018

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: 01/24/2022
• Device Catalogue Number: 74022127
• Device Lot Number: 12AM17037
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/01/2017
• Supplement Date Received by Manufacturer: 12/01/2017; 12/01/2017
• Initial Report FDA Received Date: 12/21/2017
• Supplement Report FDA Received Date: 01/03/2018; 04/11/2018
• 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: Other; Required Intervention
• Patient Age: 69 YR