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

Catalog Number	71420174
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/10/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery due to on going pain, surgeon suggested tibia appeared internally rotated.No signs of infection.
Additional Manufacturer Narrative
The associated complaint devices were not returned.The clinical/medical team concluded, related to (b)(4).No clinical supporting documentation to confirm the reported pain has been provided.Per the detail page, ¿surgeon suggested tibia appeared internally rotated.No signs of infection.¿ without the return of the explant or the requested clinical information, a thorough clinical/medical investigation cannot be rendered.Therefore, the patient¿s current status nor the future impact to the patient as a result of the reported pain can be concluded.No further clinical/medical investigation is warranted at the 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.Product was sterilized according to sterilization release documentation from quality control.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.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, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7224072
• Report Number: 1020279-2018-00080
• Device Sequence Number: 722849
• Product Code: JWH
• UDI-Device Identifier: 03596010206305
• UDI-Public: 03596010206305
• Combination Product (Y/N): N
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 04/15/2018

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: Lay User/Patient
• Device Catalogue Number: 71420174
• Device Lot Number: 15DM14553
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/11/2018
• Supplement Date Received by Manufacturer: 01/11/2018
• Initial Report FDA Received Date: 01/29/2018
• Supplement Report FDA Received Date: 04/15/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention