MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURN ART INS BCS STD 7-8 RT 9; PRSTHS,KNE,PTLLFMRTBL,SMCNSTRD,CMNTD,PLYMRMTLPLYMR

Catalog Number	74023271
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/19/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed because the polyethylene post had broken off into the femoral component.
Additional Manufacturer Narrative
The associated journey articular insert was returned and evaluated.A lab analysis conducted during this investigation noted a small anterior inferior surface edge fracture, fractured post, and articular surface wear.Damage included what appears to be edge deformation on the superior edge of one side and the post fractured surfaces.The exact cause of the post fracture and other conditions mentioned could not be determined from the investigation of the device.There were no observations of material or manufacturing deviations in the course of this investigation.A clinical analysis noted no relevant supporting clinical information will be provided, and there is no report of the patient's current condition.Therefore based on insufficient information, a clinical assessment cannot be performed at this time.A review of the manufacturing records cannot be performed as batch number was illegible.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.Should additional information be received, the complaint will be reopened.

• Brand Name: JOURN ART INS BCS STD 7-8 RT 9
• Common Device Name: PRSTHS,KNE,PTLLFMRTBL,SMCNSTRD,CMNTD,PLYMRMTLPLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7488831
• Report Number: 1020279-2018-00855
• Device Sequence Number: 13940533
• Product Code: JWH
• UDI-Device Identifier: 03596010555274
• UDI-Public: 03596010555274
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K042515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2018

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: 74023271
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/19/2018
• Supplement Date Received by Manufacturer: 04/19/2018
• Initial Report FDA Received Date: 05/04/2018
• Supplement Report FDA Received Date: 12/05/2018
• 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: Hospitalization; Required Intervention