MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN PS HIGH FLEX XLPE SZ 5-6 13MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	71453223
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/04/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to pain.Surgeon found poly and tibia loosed.All implants where removed and replaced.
Additional Manufacturer Narrative
The associated legion ps high flexion insert was returned and evaluated.The tibial component was not returned and no device information was provided neither.However, the evaluation was performed on the returned insert.A lab analysis conducted during this investigation indicated that the returned device showed scratching, burnishing, and wear on the non-articular surface of the part which were likely caused by repeated motion between the insert and the tibial baseplate.The deformation of the posterior locking detail were likely caused by having the insert sitting on top of the posterior locking region of the baseplate.No manufacturing deviations were noted during this investigation.Based on the investigation conducted, the exact cause of the insert dissociation was not able to be determined.Our investigation including a review of the manufacturing records for the insert did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Our clinical evaluation noted that no relevant clinical supporting documents were provided to conduct a medical assessment of the reported issue.No thorough clinical assessment can be performed at this time.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: LGN PS HIGH FLEX XLPE SZ 5-6 13MM
• 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: 8559555
• Report Number: 1020279-2019-01685
• Device Sequence Number: 2339524
• Product Code: JWH
• UDI-Device Identifier: 00885556033425
• UDI-Public: 00885556033425
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2019

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: 71453223
• Device Lot Number: 14AT38096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2019
• Initial Date Received by Manufacturer: 04/04/2019
• Supplement Date Received by Manufacturer: 04/04/2019
• Initial Report FDA Received Date: 04/27/2019
• Supplement Report FDA Received Date: 05/20/2019
• 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