MAUDE Adverse Event Report: SMITH AND NEPHEW, INC. LGN XLPE DISHED ISRT SZ 5-6 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71453284
Health Effect - Clinical Code	Swelling (2091)
Date of Event	09/26/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to failure of the device.Sweeling was reported.
Additional Manufacturer Narrative
The associated complaint devices were not returned.The clinical/medical team concluded, based on the clinical documentation of noted edema tracks on the mri and an x-ray showing an 8mm foreign body in the medial soft tissues of mid-left thigh approximately 1 week prior to the noted tibial tray loosening, currently unable to rule out a possible injury as a precursor and contributing factor to the tibial component loosening.The patient impact beyond the reported pain, the revision surgery (all components due to competitor revision implants), and an expected brief post-operative rehabilitative phase cannot be concluded.No further medical assessment can be rendered 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 parts revealed no prior complaints for the listed batches/failure mode.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.We consider this investigation closed.Credit cannot be issued for the devices.

• Brand Name: LGN XLPE DISHED ISRT SZ 5-6 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH AND NEPHEW, INC.; 1450 brooks road; memphis, tennessee; memphis 38116
• MDR Report Key: 7930857
• Report Number: 1020279-2018-01956
• Device Sequence Number: 1914695
• Product Code: JWH
• UDI-Device Identifier: 00885556255643
• UDI-Public: 00885556255643
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K071071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2019

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 Expiration Date: 09/26/2017
• Device Catalogue Number: 71453284
• Device Lot Number: 11CM14460
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/05/2018
• Supplement Date Received by Manufacturer: 09/05/2018
• Initial Report FDA Received Date: 10/03/2018
• Supplement Report FDA Received Date: 04/29/2019
• 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