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

Catalog Number	71926225
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/07/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that 6 years after primary tka, patient needed a revision surgery due to a fall and the patella was found to be loose.
Additional Manufacturer Narrative
The associated complaint device was returned and evaluated.The lab analysis concluded, this examination showed evidence of wear and deformation on the articulating surface of the patella.This examination also showed one damaged fixation peg as the other two pegs were missing.The cause of the two missing fixation pegs could not be determined from the investigation of the device.No evidence of material or manufacturing deviations were observed in this investigation.The clinical/medical team concluded, based on the complaint description, the root cause of the patellar loosening and subsequent revision was the reported patient fall, which could also explain the 2 missing patellar pegs.It was reported that the surgeon elected to proceed with revision of the tibial insert which is routinely performed once the knee is opened for any procedure.No further patient impact is anticipated beyond the revision procedure itself and a brief post-surgical rehabilitation phase.No further medical assessment can be rendered 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 part revealed no prior complaints for the listed batch.If new information is received in the future, this complaint can be re-opened.

• Brand Name: GEN II RESURF PATELLA 38MM
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMEN, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8210530
• Report Number: 1020279-2019-00019
• Device Sequence Number: 16195981
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2019

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: 08/06/2021
• Device Catalogue Number: 71926225
• Device Lot Number: 11HM05444
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/31/2018
• Initial Date Received by Manufacturer: 12/07/2018
• Supplement Date Received by Manufacturer: 12/07/2018
• Initial Report FDA Received Date: 01/02/2019
• Supplement Report FDA Received Date: 05/15/2019
• 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