MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN XLPE DISHED ISRT SZ 3-4 9MM; PRSTHSIS,KNEE,PATLLOFMOROTIBIAL,SMI-CONSTRAIND,CMNTD,POLYMR/MTAL/POLYMR

Catalog Number	71453277
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Information (3190)
Date of Event	04/17/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a surgical intervention was performed due to knee instability.
Additional Manufacturer Narrative
The associated genesis ii cemented tibial baseplate, legion dished insert and oxinium femoral were not returned for evaluation.Our investigation included a clinical evaluation which noted no clinical supporting documents were provided to conduct a thorough analysis of the reported issue.No medical assessment can be rendered.A review of complaint history on the listed parts revealed no additional complaints for this failure mode with the same batch number.A review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.Without the return of the actual product involved, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: LGN XLPE DISHED ISRT SZ 3-4 9MM
• Common Device Name: PRSTHSIS,KNEE,PATLLOFMOROTIBIAL,SMI-CONSTRAIND,CMNTD,POLYMR/MTAL/POLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7511023
• Report Number: 1020279-2018-00927
• Device Sequence Number: 1897769
• Product Code: JWH
• UDI-Device Identifier: 00885556255704
• UDI-Public: 00885556255704
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K071071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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): 06/13/2018

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: 08/08/2024
• Device Catalogue Number: 71453277
• Device Lot Number: 14HM06616
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/17/2018
• Supplement Date Received by Manufacturer: 04/17/2018
• Initial Report FDA Received Date: 05/14/2018
• Supplement Report FDA Received Date: 06/13/2018
• 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; Other; Required Intervention