MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GEN II CEMENTED TIBIAL B/PLATE SZ3 RIGHT; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	71420182
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/07/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed, it is unknown the reason for this revision.
Additional Manufacturer Narrative
The associated complaint devices were not returned.The clinical/medical team concluded, the implant information and the partial operative report were reviewed and is non-contributory.Therefore, due to insufficient clinical information a thorough medical investigation cannot be rendered at this time.All documents and/or images provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical investigation.Should any additional medication information be provided this complaint will be re-assessed.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 prior complaints for the listed batches/failure mode.Without the actual device involved our investigation cannot proceed.If the device or new information is received in the future, the complaints can be re-opened.No further actions are being taken at this time.

• Brand Name: GEN II CEMENTED TIBIAL B/PLATE SZ3 RIGHT
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8862833
• Report Number: 1020279-2019-02899
• Device Sequence Number: 11451693
• Product Code: JWH
• UDI-Device Identifier: 03596010206336
• UDI-Public: 03596010206336
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2019

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: 08/21/2025
• Device Catalogue Number: 71420182
• Device Lot Number: 15HM16212
• Initial Date Received by Manufacturer: 07/13/2019
• Supplement Date Received by Manufacturer: 11/04/2019
• Initial Report FDA Received Date: 08/05/2019
• Supplement Report FDA Received Date: 11/11/2019
• 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 Weight: 56