MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II TKA FEM TRIAL LT SZ 6; PROSTHESIS,KNEE,PATELLOFEMOROTIBIL,SMICONSTRAIND,CMNTD,POLYMR/METAL/POLYMR

Catalog Number	74031226
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/05/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a piece of metal fell off the back of the femoral trial into the patient.It was removed from patient and no impact to the surgery as it¿s was a large fragment.
Additional Manufacturer Narrative
The associated device was returned and evaluated.A visual examination showed a fracture and deformation of the fixation rails in the ream through slot of the femoral trial.The fracture and deformation is likely due to the load applied to the trial during the impaction of the trial onto the femur.If the loads applied exceed the strength of the material, a fracture may occur.This device was manufactured in 2013, showing signs of wear/use.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A clinical analysis indicated it was reported a piece of metal fell off back of the femoral trial and the large fragment was removed from the patient.No other clinical relevant documents were provided to conduct a thorough medical assessment.Since there was no harm to the patient or delay in the case, no further clinical/medical assessment is warranted at this time.This complaint will be re-evaluated if more information becomes available.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate further as necessary.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: JRNY II TKA FEM TRIAL LT SZ 6
• Common Device Name: PROSTHESIS,KNEE,PATELLOFEMOROTIBIL,SMICONSTRAIND,CMNTD,POLYMR/METAL/POLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7609281
• Report Number: 1020279-2018-01148
• Device Sequence Number: 16430635
• Product Code: JWH
• UDI-Device Identifier: 03596010672032
• UDI-Public: 03596010672032
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K121443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2018

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 74031226
• Device Lot Number: 13MM02453
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2018
• Supplement Date Received by Manufacturer: 06/05/2018
• Initial Report FDA Received Date: 06/18/2018
• Supplement Report FDA Received Date: 08/08/2018
• 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