MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN PS HIGH FLEX XLPE SZ 5-6 12MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	71453176
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/12/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient underwent a tkr revision on (b)(6) 2018.Patient was doing well, but fell and opened up his surgical incision.That was repaired without incident or explant on (b)(6) 2019.The patient returned with an apparent infection.An insert exchange and extension washout was performed.No delay reported, no backup device required.
Additional Manufacturer Narrative
The clinical/medical team concluded, it has been communicated via email that no relevant supporting clinical information will be provided, and there is no report of the patient's current condition.Therefore based on insufficient information, no further clinical assessment can be performed 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.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.Mimb review.Assess severity of complaint case to determine if additional actions or inputs are required for inclusion in the medical assessment.Determine if a medical assessment will be performed based on a review of the complaint details and further input from the medical director/designee.Reviewed during mimb.A medical investigation will be performed.Proceed based on information provided or available for the investigation; if no relevant clinical information is provided, recommend closure.Approved by dr.(b)(6) and/or (b)(6), medical director.A review of relevant clinical/medical information in the reported issue, inclusive of technique and patient information, to include, but not limited to: patient information.Surgical procedure/post-operative care review.Device labeling (including technique guides, ifus, etc.) it has been communicated via email that no relevant supporting clinical information will be provided, and there is no report of the patient's current condition.Therefore based on insufficient information, no further clinical assessment can be performed at this time.

• Brand Name: LGN PS HIGH FLEX XLPE SZ 5-6 12MM
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8396460
• Report Number: 1020279-2019-00937
• Device Sequence Number: 11567901
• Product Code: JWH
• UDI-Device Identifier: 00885556487099
• UDI-Public: 00885556487099
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K071071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2019

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: 71453176
• Device Lot Number: 17HM14383
• Initial Date Received by Manufacturer: 02/12/2019
• Supplement Date Received by Manufacturer: 06/11/2019
• Initial Report FDA Received Date: 03/06/2019
• Supplement Report FDA Received Date: 06/16/2019
• 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: 59 YR
• Patient Weight: 100