MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURN ART INS BCS STD 3-4 RT 9; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAIND,CEMNTD,POLYMR/METAL/POLYMR

Catalog Number	74023231
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/16/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a revision surgery was performed when the surgeon discovered the insert damaged and partly removed.The insert was replaced.
Additional Manufacturer Narrative
Investigation results: the associated complaint device was returned and evaluated.A clinical investigation concluded that this patient underwent a revision of the right total knee replacement seven years post implantation.The surgeon discovered the tip of the insert post is damaged and partly removed, potentially by reamers during retrograde nail insertion.The lab analysis concluded that the wear on the articular surface was likely due to normal articulation between the insert and femoral component.The damage seen on the anterior/superior surface of the insert could have occurred during implant removal.Damage to the insert post was potentially due to the reported retrograde nail insertion.No material or manufacturing deviations were observed.No clinically supportive documents have been provided for inclusion in this investigation.The future impact to the patient beyond the revision cannot be determined.No further clinical assessment is warranted at this time.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal any material or manufacturing deviations that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: JOURN ART INS BCS STD 3-4 RT 9
• Common Device Name: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAIND,CEMNTD,POLYMR/METAL/POLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7149602
• Report Number: 1020279-2017-01349
• Device Sequence Number: 1145241
• Product Code: JWH
• UDI-Device Identifier: 03596010554994
• UDI-Public: 03596010554994
• 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: 2010
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2018

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 Expiration Date: 02/14/2019
• Device Catalogue Number: 74023231
• Device Lot Number: 09BM12079
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/17/2017
• Supplement Date Received by Manufacturer: 12/17/2017
• Initial Report FDA Received Date: 12/27/2017
• Supplement Report FDA Received Date: 04/18/2018
• 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