MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GEN II CEMENTED TIBIAL B/PLATE SZ 8 LEFT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED.

Catalog Number	71420174
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Aspiration/Inhalation (1725)
Date of Event	08/08/2014
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a medical intervention was performed, left knee irrigation and debridement with hematoma evacuation were performed due to continue irrigation.
Additional Manufacturer Narrative
The associated complaint devices were not returned.The clinical/medical team concluded, this case reports a revision surgery was performed on the patient due to pain in the knee.The date of the initial implantation is unknown.It was further communicated that no evidence of infection was found and laxity of the components was present most notably in full flexion.Details regarding the patient¿s weight-bearing status, medical history, bone quality, and other additional clinical relevant information have not been provided.Based on the limited information provided and without the return of the device for evaluation and diagnostic images, the root cause of the reported pain and laxity of the joint cannot be determined.Should additional information becomes available this issue can be re-elevated.No further clinical assessment is warranted at this time.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 parts revealed no prior complaints for the listed batches/failure mode.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.We consider this investigation closed.

• Brand Name: GEN II CEMENTED TIBIAL B/PLATE SZ 8 LEFT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED.
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8146295
• Report Number: 1020279-2018-02725
• Device Sequence Number: 1459799
• Product Code: JWH
• UDI-Device Identifier: 03596010206305
• UDI-Public: 03596010206305
• 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: 2013
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2019

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: No Information
• Device Expiration Date: 02/22/2021
• Device Catalogue Number: 71420174
• Device Lot Number: 11BM16080
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/16/2018
• Supplement Date Received by Manufacturer: 11/16/2018
• Initial Report FDA Received Date: 12/10/2018
• Supplement Report FDA Received Date: 06/03/2019
• 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: Required Intervention
• Patient Age: 74 YR