MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II BICONVEX PAT 32MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	71420578
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/24/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patella was revised due to loosening and possible vascular necrosis of the native patella.Dr.Stated that the pegs on the original 35 mm resurfacing gen ii patella ref 71420578 were not in the same place as the cement plugs, so the component seems to have moved inside the bone.The patella was removed and replaced with a 32 mm biconvex patella (pictured).No other components were touched.No more information provided yet.
Additional Manufacturer Narrative
It was reported that the patella was revised due to loosening and possible vascular necrosis of the native patella.The affected genesis ii resurfacing patellar component was not returned for evaluation.Therefore a product analysis could not be performed.The lot number was not provided for this device.Thus, a review of the manufacturing records of the product could not be performed.Complaint history review could not be performed with any accuracy due to lack of batch number.A relationship, if any, between the device and the reported incident or adverse event could not be corroborated.A clinical evaluation noted that two pre-revision photos of radiological imaging were provided.The images confirm the anterior migration of the revised patella and the patella appears to be tracking laterally.Based on the provided imaging and complaint details, the revision was secondary to the patellar loosening possibly secondary to avascular necrosis.No further clinically relevant documentation was provided for inclusion in a medical investigation, therefore, no further medical assessment can be rendered at this time.The patient impact beyond the revision procedure cannot be determined.Without the return of the actual product involved and no batch number available, our investigation of this report is inconclusive.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: GNS II BICONVEX PAT 32MM
• 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: 8821442
• Report Number: 1020279-2019-02729
• Device Sequence Number: 16945420
• Product Code: JWH
• UDI-Device Identifier: 03596010208286
• UDI-Public: 03596010208286
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2019

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: 71420578
• Device Lot Number: 16JM05710
• Initial Date Received by Manufacturer: 06/24/2019
• Supplement Date Received by Manufacturer: 06/24/2019
• Initial Report FDA Received Date: 07/24/2019
• Supplement Report FDA Received Date: 11/07/2019
• 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