MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GEN II COCR CR NP FEMORAL COMP SZ 8 LEFT; PRSTHSS, KNEE, PTLLFMRTBIAL, SM-CNSTRND, CMNTD, POLYMER/METAL/POLYMER

Catalog Number	71420014
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Sepsis (2067); Injury (2348)
Date of Event	06/09/2011
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented acute sepsis on the knee.Revision surgery was performed to remove femoral, tibial and patellar components as well as associated cement.Antibiotic beads were implanted.
Additional Manufacturer Narrative
The associated genesis ii cobalt chrome femoral component, genesis ii cemented tibial base plate, genesis ii resurfacing patellar component and genesis ii articular liner were not returned for evaluation.Therefore a product analysis could not be performed.However, device details were provided.The manufacturing records and complaint history review was conducted.The review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.The review of the complaint history for the listed parts 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 products failed to meet any product specifications at the time of manufacture.The devices were sterilized according to sterilization release documentation from quality control.There is no information that would suggest the devices failed to meet specifications.A relationship, if any, between the devices and the reported incident or adverse event could not be corroborated.A clinical evaluation noted that based on medical documentation, the recurrent/persistent left knee joint infection/mrsa most likely resulted from the reported hematogenous spread secondary to chronic skin lesions and was the root cause of the revisions and associated complications.The patient impact beyond the reported ongoing pain, multiple surgical interventions and required antibiotic therapies secondary to persistent/chronic knee joint infections and a traumatic injury cannot be determined, as the 3rd revision indicated mssa positive cultures.No further investigation is warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.

• Brand Name: GEN II COCR CR NP FEMORAL COMP SZ 8 LEFT
• Common Device Name: PRSTHSS, KNEE, PTLLFMRTBIAL, SM-CNSTRND, CMNTD, POLYMER/METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7921491
• Report Number: 1020279-2018-01973
• Device Sequence Number: 19229031
• Product Code: JWH
• UDI-Device Identifier: 03596010205506
• UDI-Public: 03596010205506
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2019

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: 07/23/2017
• Device Catalogue Number: 71420014
• Device Lot Number: 07GM19203
• Initial Date Received by Manufacturer: 09/05/2018
• Supplement Date Received by Manufacturer: 09/05/2018
• Initial Report FDA Received Date: 10/01/2018
• Supplement Report FDA Received Date: 09/18/2019
• 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
• Patient Age: 55 YR