MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GEN II COCR PS NP FEMORAL COMPSZ 7 RIGHT; PROSTHESIS,KNEE,PATELLOFEMORTIBIL,SMICONSTRAIND,CMNTD,POLYMR/METAL/POLYMR

Catalog Number	71420124
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/18/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after evaluation, the patient was referred to a joint needle aspiration department, which confirmed the septic state and led to the isolation of the same bacterial strain.On (b)(6) 2018 the patient was therefore subjected to complete prosthetic removal surgery and replacement with an antibiotic cement spacer - surgical procedure - duration 1 hour and 48 minutes.
Additional Manufacturer Narrative
The associated complaint devices were not returned for evaluation.Our clinical evaluation noted that no relevant supporting clinical information has been provided to assist with a clinical investigation, and the patient's current condition is unknown.Therefore based on insufficient information, a clinical assessment cannot be performed at this time.Our investigation including a review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.Product was sterilized according to sterilization release documentation from quality control.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.We consider this investigation closed.Should additional information be received, the complaint will be reopened.

• Brand Name: GEN II COCR PS NP FEMORAL COMPSZ 7 RIGHT
• Common Device Name: PROSTHESIS,KNEE,PATELLOFEMORTIBIL,SMICONSTRAIND,CMNTD,POLYMR/METAL/POLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7644667
• Report Number: 1020279-2018-01220
• Device Sequence Number: 275681
• Product Code: JWH
• UDI-Device Identifier: 03596010206060
• UDI-Public: 03596010206060
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K951987
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2018

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: 02/28/2025
• Device Catalogue Number: 71420124
• Device Lot Number: 15CM01469
• Initial Date Received by Manufacturer: 06/04/2018
• Supplement Date Received by Manufacturer: 06/04/2018
• Initial Report FDA Received Date: 06/28/2018
• Supplement Report FDA Received Date: 11/07/2018
• 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
• Patient Age: 58 YR