MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GEN II RESURF PATELLA 38MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	71926225
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/02/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to patella loosening.
Additional Manufacturer Narrative
The associated complaint device was not returned.The medical investigation concluded that several attempts have been made to obtain clinical/medical documents to support this complaint.Without supporting clinical/medical documents, a thorough investigation cannot be performed.Should information become available this complaint can be re-assessed.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, the complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: GEN II RESURF PATELLA 38MM
• 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: 8929155
• Report Number: 1020279-2019-03182
• Device Sequence Number: 10835533
• Product Code: JWH
• UDI-Device Identifier: 00885556043998
• UDI-Public: 00885556043998
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2019

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 Catalogue Number: 71926225
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/02/2019
• Supplement Date Received by Manufacturer: 11/14/2019
• Initial Report FDA Received Date: 08/26/2019
• Supplement Report FDA Received Date: 11/17/2019
• 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: 61 YR