MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II BICONVEX PAT 29MM; PROSTHESIS KNE PATELLOFEMOROTIBIAL SEMICONSTRAINED CMNTD POLYMERMETALPOLYMER

Catalog Number	71420570
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Injury (2348)
Date of Event	07/23/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery of the patella was performed due to a loosening.
Additional Manufacturer Narrative
It was reported that a revision surgery of the patella was performed due to a loosening.The affected genesis ii biconvex patellar component was not returned for evaluation.Therefore a product analysis could not be performed.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 or adverse event could not be corroborated.A medical analysis noted that the operative report was provided, but it did not include any findings, therefore it does not contribute to this investigation.All of documents provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical investigation.Without the return of the actual product involved and no requested clinical information 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.We consider this investigation closed.

• Brand Name: GNS II BICONVEX PAT 29MM
• Common Device Name: PROSTHESIS KNE PATELLOFEMOROTIBIAL SEMICONSTRAINED CMNTD POLYMERMETALPOLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8890928
• Report Number: 1020279-2019-03040
• Device Sequence Number: 11586950
• Product Code: JWH
• UDI-Device Identifier: 03596010208279
• UDI-Public: 03596010208279
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2019

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: 09/17/2026
• Device Catalogue Number: 71420570
• Device Lot Number: 16JM09070
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/23/2019
• Supplement Date Received by Manufacturer: 11/12/2019
• Initial Report FDA Received Date: 08/13/2019
• Supplement Report FDA Received Date: 11/21/2019
• 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