MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GEN II 7.5MM RESUR PAT 35MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	71932637
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	02/20/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that revision surgery was performed due to dislocation, damaged and fracture of the patella component.
Additional Manufacturer Narrative
The associated genesis ii resurfacing patellar component was returned and evaluated.A lab analysis conducted during this investigation noted that the patella has cement remaining within the cement pocket.All three posterior pegs showed signs of plastic deformation.Minimal wear was noted on the articulating surface.No material or manufacturing deviations were observed during this investigation.A dimensional evaluation was attempted; damage/deformation at several features of the device would not allow for accurate measurement.Our investigation including a review of the manufacturing records for the listed batch 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 failure mode with the same batch number.A clinical analysis noted without the requested supporting clinical documents a thorough medical investigation cannot be rendered.Should new information become available in the future this complaint can be re-assessed.

• Brand Name: GEN II 7.5MM RESUR PAT 35MM
• 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: 8430547
• Report Number: 1020279-2019-01089
• Device Sequence Number: 16891331
• Product Code: JWH
• UDI-Device Identifier: 00885556057117
• UDI-Public: 00885556057117
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2019

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: 71932637
• Device Lot Number: 17BM05271
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2019
• Initial Date Received by Manufacturer: 02/25/2019
• Supplement Date Received by Manufacturer: 02/25/2019
• Initial Report FDA Received Date: 03/18/2019
• Supplement Report FDA Received Date: 05/16/2019
• 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