MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURN ART INS BCS STD 7-8 RT10; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SMICONSTRAIND,CMNTD,POLYMR/METL/POLYMR

Catalog Number	74023272
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	05/08/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient dislocated the femoral component over post in high flexion.The surgeon found the tip of insert had broken off and was floating free in knee.The insert was removed and replaced.
Additional Manufacturer Narrative
The associated complaint device was returned and evaluated.A lab analysis indicated gouged material is shown near the insertion/extraction slot along both the top and bottom of the tibial implant base on the medial side.Damage along the medial articular surface is noted with little wear outside of the gouged material.A pattern of wear and then fracture is shown along the top of the broken post on the tibia base where the cam articulates.The post tip has broken off and gouged material is seen along the posterior side where the cam articulates.Material damage continues onto the distal side of the broken post tip until a cleavage plane appears.No material or manufacturing defects were observed in the course of this investigation.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 for the listed part did not reveal additional complaints for the listed batch.A clinical analysis indicated that based on the available information, the root cause of the insert tip breakage cannot be concluded.Several attempts have been made to obtain clinical/medical documents to no avail.Without supporting clinical/medical documents a thorough investigation cannot be performed.Should information become available this complaint can be re-assessed.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: JOURN ART INS BCS STD 7-8 RT10
• Common Device Name: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SMICONSTRAIND,CMNTD,POLYMR/METL/POLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7530751
• Report Number: 1020279-2018-00987
• Device Sequence Number: 1224927
• Product Code: JWH
• UDI-Device Identifier: 03596010555281
• UDI-Public: 03596010555281
• 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 Implanted Year: 2008
• 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): 11/29/2018

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: 06/27/2016
• Device Catalogue Number: 74023272
• Device Lot Number: 06FM06420
• Initial Date Received by Manufacturer: 05/09/2018
• Supplement Date Received by Manufacturer: 05/09/2018
• Initial Report FDA Received Date: 05/21/2018
• Supplement Report FDA Received Date: 11/29/2018
• 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
• Patient Age: 75 YR