MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN CR HIGH FLEX XLPE SZ 1-2 9MM; PROSTHSIS,KNEE,PATLLOFEMOROTIBIL,SMICONSTRAIND,CMNTD,POLYMR/METL/POLYMR

Catalog Number	71453101
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	06/28/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that at time of primary surgery the patient went to great lengths via diet and medication to gain control over diabetes.Since this time the patient has regressed to now be a poorly controlled diabetic.The patient has had recurrent chest infections treated with antibiotics.Recently developed symptoms of infected knee.All implants were removed.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A clinical evaluation was conducted and this is a complaint from australia reporting the revision of a genesis knee secondary to infections.The primary surgery was performed in (b)(6) 2017.The revision was done 8 months later in (b)(6) 2018.Several attempts have been made to obtain clinical/medical documents to no avail.With the original complaint entry, it was noted that, "surgeon does not fault the products.There are no retrieved implants for analysis".Without supporting clinical/medical documents a thorough investigation cannot be performed.Should information become available this complaint can be re-assessed.A review of complaint history on the listed parts revealed no prior complaints for the listed batches with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.This included a review of sterilization documents which indicated that the product was sterilized according to sterilization release documentation.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.Credit cannot be issued for these devices.

• Brand Name: LGN CR HIGH FLEX XLPE SZ 1-2 9MM
• Common Device Name: PROSTHSIS,KNEE,PATLLOFEMOROTIBIL,SMICONSTRAIND,CMNTD,POLYMR/METL/POLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7703763
• Report Number: 1020279-2018-01329
• Device Sequence Number: 752002
• Product Code: JWH
• UDI-Device Identifier: 00885556033432
• UDI-Public: 00885556033432
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K071071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 07/19/2018

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: 71453101
• Device Lot Number: 17CM04711
• Initial Date Received by Manufacturer: 06/29/2018
• Supplement Date Received by Manufacturer: 06/29/2018
• Initial Report FDA Received Date: 07/19/2018
• Supplement Report FDA Received Date: 10/01/2018
• 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: 73 YR
• Patient Weight: 90