MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GEN II RESURF PATELLA 38MM; PRSTHSS, KNEE, PTLLFMRTBIAL, SM-CNSTRND, CMNTD, POLYMER/METAL/POLYMER

Catalog Number	71926225
Medical Device Problem Codes	Mechanical Problem (1384); Unstable (1667)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/02/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that revision surgery was performed.
Additional Manufacturer Narrative
This report contains now the correct information for this case.The previous report submitted contains information about case under 1020279-2018-02050.
Event or Problem Description
It was reported that the doctor feels the pegs sheered off of the implant.Device was explanted in a revision surgery.
Additional Manufacturer Narrative
The associated complaint device was not returned.A clinical evaluation was conducted and insufficient clinically relevant information was provided, therefore, a through medical assessment could not be performed.However, it was reported that the surgeon believed the pegs sheared off of the patellar component (which were recovered) and the issue was resolved without patient injury or surgical delay by explanting the broken patella and implanting a new one.The patient impact beyond the reported sheared pegs and subsequent revision and an expected brief rehabilitation period cannot be determined.Should clinically relevant documentation and/or the explant return for evaluation, the clinical/medical task may be re-evaluated.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: GEN II RESURF PATELLA 38MM
• Common Device Name: PRSTHSS, KNEE, PTLLFMRTBIAL, SM-CNSTRND, CMNTD, POLYMER/METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7928556
• Report Number: 1020279-2018-01965
• Device Sequence Number: 1400128
• Product Code: JWH
• UDI-Device Identifier: 00885556030912
• UDI-Public: 00885556030912
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/19/2018

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: 03/12/2022
• Device Catalogue Number: 71926225
• Device Lot Number: 12CM09147
• Initial Date Received by Manufacturer: 09/05/2018
• Supplement Date Received by Manufacturer: 09/05/2018; 09/05/2018
• Initial Report FDA Received Date: 10/02/2018
• Supplement Report FDA Received Date: 10/03/2018; 12/19/2018
• 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