MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN PS HIGH FLEX XLPE SZ 1-2 12MM; PRSTHSIS,KNEE,PATLLOFMOROTIBIL,SMICONSTRAIND,CMNTD,POLYMR/METL/POLYMR

Catalog Number	71453172
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/03/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to suspicion of infection.During revision surgery, it was discovered that the problem was a disassociation.
Additional Manufacturer Narrative
The associated complaint device was returned and evaluated.The lab analysis concluded, the burnishing and scratches on the inferior surface of the insert was likely caused by repeated motion between the insert and the tibial baseplate, and could have been caused during or after the reported insert loosening.The anterior lock region appeared undamaged.Due to damage on the posterior locking mechanism, this feature could not be inspected.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.The clinical/medical team concluded, all documents and images provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical investigation.The root cause for the disassociation cannot be concluded based on the evaluation of the returned component.Without supporting clinical/medical documents a thorough investigation cannot be performed.Should information become available this complaint can be re-assessed.No patient information was provided for this assessment.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 part revealed no prior complaints for the listed batch.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: LGN PS HIGH FLEX XLPE SZ 1-2 12MM
• Common Device Name: PRSTHSIS,KNEE,PATLLOFMOROTIBIL,SMICONSTRAIND,CMNTD,POLYMR/METL/POLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7799383
• Report Number: 1020279-2018-01544
• Device Sequence Number: 13846370
• Product Code: JWH
• UDI-Device Identifier: 00885556486894
• UDI-Public: 00885556486894
• 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: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2019

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: 07/17/2025
• Device Catalogue Number: 71453172
• Device Lot Number: 15GM12559
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2018
• Initial Date Received by Manufacturer: 08/03/2018
• Supplement Date Received by Manufacturer: 08/03/2018
• Initial Report FDA Received Date: 08/20/2018
• Supplement Report FDA Received Date: 03/26/2019
• 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