MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN CR HIGH FLEX XLPE SZ 3-4 9MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	71453111
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/16/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to dislocation and a feeling of wrongness.Three parts were removed: legion ox femoral component, legion base plate, legion insert.These components were replaced with: legion ox femoral component and legion insert.Pre-existing conditions: osteoarthritis.
Additional Manufacturer Narrative
The devices, used in treatment, were not returned for evaluation.A clinical evaluation was conducted and this is a complaint from japan reporting the revision of a knee secondary to a dislocation and a ¿feeling of wrongness¿.Several attempts were made to obtain clinical/medical information to no avail.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.No potential probable cause could be identified with the limited information provided.Some potential probable causes of the event could be malalignment or inadequate device selection.Surgeon did not fault the device.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, these complaints can be re-opened.No further actions are being taken at this time.

• Brand Name: LGN CR HIGH FLEX XLPE SZ 3-4 9MM
• 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: 9187435
• Report Number: 1020279-2019-03648
• Device Sequence Number: 2763143
• 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: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2020

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: 07/19/2026
• Device Catalogue Number: 71453111
• Device Lot Number: 16GM14741
• Initial Date Received by Manufacturer: 09/18/2019
• Supplement Date Received by Manufacturer: 01/14/2020
• Initial Report FDA Received Date: 10/14/2019
• Supplement Report FDA Received Date: 01/15/2020
• 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: GENII TIBIAL BP 71420182/16GT73764.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention