MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN XLPE PS INSERT SZ 7-8 13MM; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAIND,CEMNTD,POLYMR/METAL/POLYMER

Catalog Number	71453259
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	01/09/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a revision surgery was performed due to unexplained pain.Surgeon realized poly was not fully locked in.
Additional Manufacturer Narrative
The associated complaint device was not returned.The clinical/medical team concluded, it was reported post total knee revision for unexplained pain (side of implantation and length of time in situ is unknown).Per the detail page, upon opening joint, it was determined the poly was not fully locked in.No clinically relevant information has been provided for inclusion in this investigation.Without the explant or the requested clinical information, the root cause of the pain cannot be determined.The future impact to the patient beyond the post knee revision cannot be determined.No further clinical/medical.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.

• Brand Name: LGN XLPE PS INSERT SZ 7-8 13MM
• Common Device Name: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAIND,CEMNTD,POLYMR/METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7189496
• Report Number: 1020279-2018-00048
• Device Sequence Number: 111373
• Product Code: JWH
• UDI-Device Identifier: 00885556255780
• UDI-Public: 00885556255780
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K071071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2018

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: 11/19/2021
• Device Catalogue Number: 71453259
• Device Lot Number: 11LM12267
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/09/2018
• Supplement Date Received by Manufacturer: 01/09/2018
• Initial Report FDA Received Date: 01/15/2018
• Supplement Report FDA Received Date: 04/24/2018
• 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: 78 YR