MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GEN II COCR CR NP FEMORAL COMP SZ 8 LEFT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71420014
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	07/17/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed on the patient for the removal of loose femoral component.No delay or additional injuries related.Antibiotic spacer was inserted.Tibial poly was replaced, but no failure reported.
Additional Manufacturer Narrative
The associated complaint device was not returned.A clinical evaluation was conducted and 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 (b)(6) and associated complications.An additional surgical procedure/debridement with additional iv antibiotics for a second isolated organism was required as a direct result of a traumatic fall with subsequent wound dehiscence just weeks s/p the 2nd (2-stage) revision.The 3rd (2-stage) revision was due to the reported pain secondary to lateral displacement/migration/loosening of the proximal stem in the mid to distal femur in the presence of (3/5) positive cultures for mssa.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 (2-stage) revision indicated mssa positive cultures.No further medical assessment can be rendered at this time.A review of complaint history on the listed part revealed 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.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.

• Brand Name: GEN II COCR CR NP FEMORAL COMP SZ 8 LEFT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7922096
• Report Number: 1020279-2018-01971
• Device Sequence Number: 1787189
• 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 Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2019

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
• Was Device Available for Evaluation?: No
• 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: 03/22/2019
• 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
• Patient Age: 61 YR