MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GEN II RESURF PATELLA 41MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	71926226
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Injury (2348)
Date of Event	07/24/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a patella revision surgery due to loosening.The patient injured his contralateral leg 6 months ago, which led him to have to limp around, which in turn made his tkr very painful.Upon opening up the joint, it was discovered that the patella component was loose, misshapen and one of the fixation pegs had broken off.Dr believes that due to his change in gait after his injury to the other leg, abnormal forces were put into the patella component, loosening and damaging it.
Additional Manufacturer Narrative
It was reported a revision surgery due to loosening.The patient injured his leg 6 months ago.It was discovered during surgery that one of the fixation pegs had broken off.The affected genesis ii resurfacing patellar component was returned for evaluation.A lab analysis conducted during this investigation indicated that the articulating surface of the patella implant appears undamaged.Two fixation posts are visible on the inferior surface.One fixation post is mostly missing, and what appears to be cement on the inferior surface.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 the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A relationship, if any, between the device and the reported incident could not be corroborated.It was reported that the doctor believes that due to his change in gait after his injury to the other leg, abnormal forces were put into the patella component, loosening and damaging it.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.No further investigation warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: GEN II RESURF PATELLA 41MM
• 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: 8883000
• Report Number: 1020279-2019-03007
• Device Sequence Number: 2730735
• Product Code: JWH
• UDI-Device Identifier: 03596010587596
• UDI-Public: 03596010587596
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2019

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: 71926226
• Device Lot Number: 16LM16711
• Initial Date Received by Manufacturer: 07/24/2019
• Supplement Date Received by Manufacturer: 07/24/2019
• Initial Report FDA Received Date: 08/12/2019
• Supplement Report FDA Received Date: 11/20/2019
• 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