MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY BCS II FEMORAL OXIN LT SZ 5; PRSTHSS,KNE,PTLLFMRTIBL,SMCNSTRND,CMNTD,PLYMRMTLPLYMR

Catalog Number	74022125
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	11/20/2014
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to condyle metaphyseal compression fracture consistent with knee pain and difficulty walking.
Additional Manufacturer Narrative
The associated complaint devices were not returned for evaluation.A clinical investigation concluded that primary surgery was complicated with a periprosthetic fracture.The patient opted to not have urgent surgery and she ¿went out¿ to heal with a mal-union and loss of range of motion.Reportedly, over time she found herself even more limited and accepted the offer of a revision.A review of the manufacturing records did not reveal any material or manufacturing deviations that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.All documents and images provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical investigation.In conclusion, the root cause of the original ¿peri-prosthetic fracture¿ cannot be concluded.No x-rays or clinical explanation was submitted.The subsequent revision was most likely required because of the initial periprosthetic fracture and the mal-union.The patient¿s body habitus could also have contributed to the issue.No current information regarding the patient¿s current status has been presented.The outcome of this event is reported as resolved.Based on this investigation, the need for corrective action is not indicated.If the device or new information is received in the future, this complaint can be re-opened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: JRNY BCS II FEMORAL OXIN LT SZ 5
• Common Device Name: PRSTHSS,KNE,PTLLFMRTIBL,SMCNSTRND,CMNTD,PLYMRMTLPLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7148986
• Report Number: 1020279-2017-01347
• Device Sequence Number: 11040218
• Product Code: JWH
• UDI-Device Identifier: 00885556170410
• UDI-Public: 00885556170410
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2018

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 Catalogue Number: 74022125
• Device Lot Number: 14DM0796
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/14/2017
• Supplement Date Received by Manufacturer: 12/14/2017
• Initial Report FDA Received Date: 12/27/2017
• Supplement Report FDA Received Date: 04/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 74022224/14HM06433; 74024838/13LM10928
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 59 YR