MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II BICONVEX PAT 26MM; PRSTHSS, KNEE, PATELLOFEMOROTIBIAL, SM-CNSTRND, CMNTD, POLYMER/METAL/POLYMER

Catalog Number	71420568
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/22/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient had pain and cracking in knee.X-ray and scintigraphy have shown a loosening of the patella implant.
Additional Manufacturer Narrative
The associated genesis ii biconvex patella component was returned and evaluated.A lab analysis conducted during this investigation noted minor scratches and burnishing observed on the articular surface of the patella implant could have been caused by third-body particulate (bone, bone cement, etc.), or during removal of the implant.Cement was still embedded around the cement groove of the implant.Damage was observed on the fixation peg.No material or manufacturing deviations were observed in the course of this investigation.Our investigation including a review of review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.The devices were manufactured in 2014.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 evaluation noted that based on the information provided, the reason for the patellar loosening cannot be concluded but an infectious etiology has been ruled out.The patient¿s post-operative condition is unknown at this time and future patient impact beyond the revision cannot be determined.No further clinical assessment is warranted.We consider this investigation closed.Should additional information be received, the complaint will be reopened.

• Brand Name: GNS II BICONVEX PAT 26MM
• Common Device Name: PRSTHSS, KNEE, PATELLOFEMOROTIBIAL, SM-CNSTRND, CMNTD, POLYMER/METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7648765
• Report Number: 1020279-2018-01226
• Device Sequence Number: 184271
• Product Code: JWH
• UDI-Device Identifier: 03596010208262
• UDI-Public: 03596010208262
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/17/2024
• Device Catalogue Number: 71420568
• Device Lot Number: 14HM14065
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/01/2018
• Supplement Date Received by Manufacturer: 06/01/2018
• Initial Report FDA Received Date: 06/28/2018
• Supplement Report FDA Received Date: 11/22/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 69 YR