MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN XLPE DISHED ISRT SZ 3-4 11M; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	71453278
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/12/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to unstable total knee with significant collateral instability, constrained femoral implant and constrained insert.No more information available.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A clinical evaluation was conducted and no clinically relevant supporting documentation was provided; therefore, a thorough medical investigation could not be performed.Should clinical documentation become available in the future, the clinical/medical task may be re-evaluated.No further medical assessment is warranted at this time.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history on the listed parts revealed no prior complaints for the listed batches with the same failure mode.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.

• Brand Name: LGN XLPE DISHED ISRT SZ 3-4 11M
• 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: 8582846
• Report Number: 1020279-2019-01777
• Device Sequence Number: 16877734
• Product Code: JWH
• UDI-Device Identifier: 00885556255698
• UDI-Public: 00885556255698
• Combination Product (Y/N): N
• PMA/510(K) Number: K071071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2019

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: 71453278
• Device Lot Number: 18CM11468
• Initial Date Received by Manufacturer: 04/13/2019
• Supplement Date Received by Manufacturer: 04/13/2019
• Initial Report FDA Received Date: 05/06/2019
• Supplement Report FDA Received Date: 10/22/2019
• 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