MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURN ART INS BCS STD 5-6 RT10; PRSTHSS,KNE,PTLFMRTBL,SMCNSTRND,CMNTD,PLYMRMTLPLYMR

Catalog Number	74023252
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	03/29/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to instability for the right knee and dislocation of insert following fall.
Additional Manufacturer Narrative
The associated journey bcs articular inserts were not returned for evaluation.Our investigation including review of the manufacturing records for the listed batches did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.A clinical evaluation noted that based on the information provided, the dislocation of the right knee was due to the fall.The future impact to the patient beyond the revision cannot be concluded.No further clinical/medical assessment is warranted at this time.Without the return of the actual product involved, our investigation of this report is inconclusive.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.Lot number corrected.

• Brand Name: JOURN ART INS BCS STD 5-6 RT10
• Common Device Name: PRSTHSS,KNE,PTLFMRTBL,SMCNSTRND,CMNTD,PLYMRMTLPLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7444534
• Report Number: 1020279-2018-00777
• Device Sequence Number: 11036079
• Product Code: JWH
• UDI-Device Identifier: 03596010555144
• UDI-Public: 03596010555144
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K042515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2018

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: 74023252
• Device Lot Number: 09BM15333
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/02/2018
• Supplement Date Received by Manufacturer: 04/02/2018
• Initial Report FDA Received Date: 04/19/2018
• Supplement Report FDA Received Date: 11/18/2018
• 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