MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION CR HI FLEX XLPE ISRT 7-8 12MM; PRSTHIS,KNEE,PATLLFEMRTIBIL,SMICONSTRAIND,CMNTD,POLYMR/METL/POLYMR

Catalog Number	71453188
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/14/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery of the poly was performed due to infection.Surgeon does not blame the product.No further information is available.
Additional Manufacturer Narrative
The associated complaint device was not returned.A clinical evaluation was conducted and no relevant clinical information was provided to conduct a thorough clinical investigation.The impact to the patient beyond the revision cannot be concluded.No further clinical/medical assessment is warranted at this time.A review of complaint history on the listed part revealed no prior complaints for the listed batch 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.This included a review of sterilization documents which indicated that the product was sterilized according to sterilization release documentation.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.We consider this investigation closed.

• Brand Name: LEGION CR HI FLEX XLPE ISRT 7-8 12MM
• Common Device Name: PRSTHIS,KNEE,PATLLFEMRTIBIL,SMICONSTRAIND,CMNTD,POLYMR/METL/POLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7835039
• Report Number: 1020279-2018-01674
• Device Sequence Number: 11154332
• Product Code: JWH
• UDI-Device Identifier: 00885556487594
• UDI-Public: 00885556487594
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 12/22/2018

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 Catalogue Number: 71453188
• Device Lot Number: 16KM19683
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/14/2018
• Supplement Date Received by Manufacturer: 08/14/2018
• Initial Report FDA Received Date: 08/30/2018
• Supplement Report FDA Received Date: 12/22/2018
• 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; Required Intervention