MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURN ART INS BCS STD 7-8 LT15; PRSTHSS,KNE,PTLLFMRTBL,SMCNSTRND,CMNTD,PLYMRMTLPLYMR

Catalog Number	74023285
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	05/30/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to fractured device that caused a dislocation.
Additional Manufacturer Narrative
The associated complaint device was returned and evaluated.A visual inspection of the returned journey insert was examined visually and using optical microscopy.Minor abrasion, discoloration and deformation were observed in the bearing regions on the superior surface of the insert.The inferior surface of the insert also displayed minor abrasion, burnishing and deformation.The bcs post was fractured near the tip.Some material deformation was observed on the bcs post which may have been caused by repeated contact with the femoral cam combined with excessive loads.The clinical/medical team concluded, without the requested supporting clinical documents, or x-rays a thorough clinical/medical investigation cannot be performed.However, based on the product evaluation this fracture could have been caused by repeated posterior impingement of the femoral cam on the ps post combined with excessive loads.The resultant damage on the ps post could have created a stress concentration which led to the insert fracture.The further impact to the patient cannot be concluded due to the lack of supporting documents.This complaint will be re-evaluated if more information becomes available.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 part revealed no prior complaints for the listed batch.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.Credit will not be issued for the device.

• Brand Name: JOURN ART INS BCS STD 7-8 LT15
• Common Device Name: PRSTHSS,KNE,PTLLFMRTBL,SMCNSTRND,CMNTD,PLYMRMTLPLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7571750
• Report Number: 1020279-2018-01065
• Device Sequence Number: 19335898
• Product Code: JWH
• UDI-Device Identifier: 03596010555380
• UDI-Public: 03596010555380
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K042515
• 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): 06/05/2018

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 Expiration Date: 09/27/2016
• Device Catalogue Number: 74023285
• Device Lot Number: 06JM03197
• Initial Date Received by Manufacturer: 05/30/2018
• Supplement Date Received by Manufacturer: 05/30/2018
• Initial Report FDA Received Date: 06/05/2018
• Supplement Report FDA Received Date: 10/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention