MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN CR HIGH FLEX XLPE SZ 3-4 9MM; PRSTHSS, KNEE, PTLLFMRTBIAL, SM-CNSTRND, CMNTD, POLYMER/METAL/POLYMER

Catalog Number	71453111
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/21/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed on knee to replace the insert due to infection.
Additional Manufacturer Narrative
The associated complaint device was not returned.The clinical/medical team concluded, insufficient clinically relevant documentation was provided, therefore, a thorough medical investigation could not be performed.However, it was communicated that due to infection, one insert component was revised approximately 3 months post bilateral tka/implantation.No further clinically relevant documentation and/or information were provided, therefore the root cause of the reported infection remains unknown.The patient impact beyond the revision (single poly exchange) for infection, probable additional antibiotic therapy, and an expected post-op convalescence period cannot be determined.No further medical assessment is warranted at this time.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed part revealed no prior complaints for the listed batch.Product was sterilized according to sterilization release documentation from quality control.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.

• Brand Name: LGN CR HIGH FLEX XLPE SZ 3-4 9MM
• Common Device Name: PRSTHSS, KNEE, PTLLFMRTBIAL, SM-CNSTRND, CMNTD, POLYMER/METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7908161
• Report Number: 1020279-2018-01830
• Device Sequence Number: 13824173
• Product Code: JWH
• UDI-Device Identifier: 00885556033975
• UDI-Public: 00885556033975
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K071071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 04/01/2019

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: 71453111
• Device Lot Number: 17HM09442
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/28/2018
• Supplement Date Received by Manufacturer: 08/28/2018
• Initial Report FDA Received Date: 09/25/2018
• Supplement Report FDA Received Date: 04/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 71420054-17LM18077; 71420182_14KMB0119A
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention